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Trial record 8 of 293 for:    retinopathy of prematurity

IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01096784
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Retinopathy of Prematurity (ROP)
Intervention Drug: rhIGF-I/rhIGFBP-3
Enrollment 121
Recruitment Details The study was conducted in multiple centres in Italy, the Netherlands, Poland, Sweden, the United Kingdom and the United States between 18 Jun 2010 and 30 March 2016.
Pre-assignment Details A total of 121 participants were enrolled and randomized into the study.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description Participants received insulin-like growth factor (rhIGF-I)/insulin-like growth factor binding protein-3 (rhIGFBP-3) 250 microgram per kilogram (mcg/kg) for 24 hours through continuous intravenous (IV) infusion from Day 0 up to 29 weeks 6 days of post-menstrual age (PMA). Participants in this control group do not received any treatment other than the standard care.
Period Title: Overall Study
Started 61 60
Completed 46 46
Not Completed 15 14
Reason Not Completed
Withdrawal by Subject             2             1
Adverse Event             11             9
Protocol Deviation             2             2
Administrative Decision             0             1
Other Unspecified             0             1
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control) Total
Hide Arm/Group Description Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA. Participants in this control group do not received any treatment other than the standard care. Total of all reporting groups
Overall Number of Baseline Participants 61 60 121
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) set included all enrolled participants for whom a randomization number was assigned.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 61 participants 60 participants 121 participants
25.60  (1.207) 25.62  (1.397) 25.61  (1.300)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Female
22
  36.1%
21
  35.0%
43
  35.5%
Male
39
  63.9%
39
  65.0%
78
  64.5%
1.Primary Outcome
Title Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
Hide Description ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome. The maximum severity of ROP across all time points was assessed from 31 PMA weeks up to 40 PMA Weeks +/- 4 days (end of study).
Time Frame End of study
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who received the study drug and participants in the control group who received Standard of Care.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: participants
ROP of Stage "0" 14 24
ROP of Stage "1" 4 4
ROP of Stage "2" 17 13
ROP of Stage "3" 6 3
ROP of Stage "3+" 6 6
ROP of Stage "4" 0 0
ROP of Stage "5" 0 0
Missing 14 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhIGF-1/rhIGFBP-3, Standard of Care (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0642
Comments [Not Specified]
Method CMH Row Mean Score Test
Comments [Not Specified]
2.Secondary Outcome
Title Time to Discharge From Neonatal Intensive Care (TDNIC)
Hide Description [Not Specified]
Time Frame Day 0 to 40 Weeks Post Menstrual Age (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS with number of participants evaluable for this outcome.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 37 31
Median (Full Range)
Unit of Measure: Days
82.00
(69.00 to 96.00)
74.00
(69.00 to 93.00)
3.Secondary Outcome
Title Number of Participants With Bronchopulmonary Dysplasia (BPD)
Hide Description

Severity of BPD as mild, moderate and severe were based on the National Institute of Child Health and Human Development (NICHD) guidelines for preterm infants born at gestational age (GA) less than (<) 32 weeks.

Mild: oxygen requirement during the first 28 days but in room air at PMA 36 weeks or discharge to home, whichever comes first.

Moderate BPD: oxygen requirement during the first 28 days and oxygen <30 percent (%) at PMA 36 weeks or discharge to home, whichever comes first.

Severe BPD: oxygen requirement during the first 28 days and oxygen greater than equal (≥)30% through head hood or nasal canula, or continuous positive airway pressure, or mechanical ventilation, or high flow nasal cannula ≥2 L/min at PMA 36 weeks or discharge to home, whichever comes first.

Time Frame At 36 Weeks Post Menstrual Age
Hide Outcome Measure Data
Hide Analysis Population Description
FAS with participants evaluable for this outcome.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 47 49
Measure Type: Number
Unit of Measure: participants
No BPD 4 4
Mild 23 16
Moderate 9 5
Severe 10 22
Unable to determine 1 2
4.Secondary Outcome
Title Rate of Change in Body Weight
Hide Description The rate of change is the rate of specific body weight change per day in kilogram (kg).
Time Frame Day 0 to 40 Weeks Post Menstrual Age (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Mean (95% Confidence Interval)
Unit of Measure: kilogram per day (kg/day)
0.021
(0.019 to 0.022)
0.023
(0.021 to 0.024)
5.Secondary Outcome
Title Rate of Change in Length
Hide Description The rate of change is the length change per day in centimeter (cm).
Time Frame Day 0 to 40 Weeks Post Menstrual Age (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Mean (95% Confidence Interval)
Unit of Measure: centimeter per day (cm/day)
0.141
(0.0132 to 0.149)
0.156
(0.147 to 0.164)
6.Secondary Outcome
Title Rate of Change in Head Circumference
Hide Description The rate of change is the head circumference change per day in centimetre (cm).
Time Frame Day 0 to 40 Weeks Post Menstrual Age (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Mean (95% Confidence Interval)
Unit of Measure: cm/day
0.115
(0.109 to 0.121)
0.119
(0.113 to 0.125)
7.Secondary Outcome
Title Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS
Hide Description Brain volume was measured using cerebral magnetic resonance imaging (MRI). Brain volume included cerebrospinal volume, gray matter volume, white matter volume, and total cerebellar volume
Time Frame 40 Weeks PMA/ (EOS) +/- 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: cubic centimeter
Cerebrospinal Fluid Volume Number Analyzed 45 participants 40 participants
87.94  (26.788) 93.70  (25.540)
Gray Matter Volume Number Analyzed 45 participants 40 participants
206.34  (31.797) 221.98  (33.827)
White Matter Volume Number Analyzed 45 participants 40 participants
110.23  (25.565) 117.62  (24.422)
Total Cerebellar Volume Number Analyzed 45 participants 41 participants
18.27  (5.302) 19.20  (4.854)
8.Secondary Outcome
Title Percentage of Participants With Intraventricular Hemorrhage (IVH)
Hide Description Development of intraventricular hemorrhage was assessed by cerebral ultrasound and coded as a binary endpoint (presence or absence of IVH).
Time Frame Day 0 to 40 Weeks Post Menstrual Age (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: percentage of participants
Yes 19.67 30.0
No 80.33 70.0
9.Secondary Outcome
Title Area Under Curve for Maximum Severity of ROP Stage (AUC for ROP)
Hide Description Integration of the maximum severity of ROP stage and the duration of the time interval with respect to each retinal examination. AUC for the maximum severity of ROP was calculated using the trapezoidal rule. The area between each 2 visits was calculated by multiplying the average of the maximum severities of the 2 visits by the difference in days and analyzed using the van Elteren test. ROP is classified according to the International Classification and is subdivided into 5 stages (1-5) with higher values representing greater severity.
Time Frame Every 1-2 weeks starting at 31 weeks PMA/ EOS +/- 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with number of participants evaluable for this outcome.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 42 49
Mean (Standard Deviation)
Unit of Measure: ROP severity score*days
47.95  (47.384) 32.17  (40.151)
10.Secondary Outcome
Title Percentage of Participants With Maximum Severity of ROP Stage Greater Than or Equal to 3 at Any Time During the Study
Hide Description ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome.
Time Frame Day 0 to 40 Weeks Post Menstrual Age (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: Percentage of participants
Yes 25.53 18.00
No 74.47 82.00
11.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product.
Time Frame Day 0 to 40 Weeks Post Menstrual Age (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAF) included all randomized participants who received the study drug and participants in the control group who received standard of care, and for whom at least 1 safety assessment was completed.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: participants
Participants with TEAE 60 60
Participants with TESAE 48 37
12.Secondary Outcome
Title Percentage of Serum IGF-1 Concentrations Falling Within Target Range After Infusion of rhIGF-1/rhIGFBP-3
Hide Description Serum samples were collected from treated and control participants for quantification of IGF-1 using validated immunoassays. Target range of serum IGF-1 was 28-109 mcg/L. The percentage of serum IGF-1 levels across treated participants that fall within the range was reported.
Time Frame Day 0 to 40 Weeks Post Menstrual Age (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was analysed.
Arm/Group Title rhIGF-I/rhIGFBP-3 Control
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Measure Type: Number
Unit of Measure: percentage of serum concentration
66.23 6.28
13.Secondary Outcome
Title Serum Concentrations of IGFBP-3 After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3
Hide Description [Not Specified]
Time Frame Day 0 and Week 40 Post Menstrual Age
Hide Outcome Measure Data
Hide Analysis Population Description
FAS.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: microgram per liter
Day 0 Number Analyzed 60 participants 60 participants
494.2  (200.38) 469.9  (180.52)
Week 40 Number Analyzed 47 participants 46 participants
830.1  (200.17) 882.1  (274.43)
14.Secondary Outcome
Title Serum Concentrations of Acid Labile Sub-unit (ALS) After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3
Hide Description [Not Specified]
Time Frame Day 7 and Week 40 Post Menstrual Age
Hide Outcome Measure Data
Hide Analysis Population Description
FAS.
Arm/Group Title rhIGF-1/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description:
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Participants in this control group do not received any treatment other than the standard care.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: microgram per liter
Day 7 Number Analyzed 60 participants 60 participants
411.9  (237.91) 500.3  (350.59)
Week 40 Number Analyzed 47 participants 46 participants
1804.6  (629.61) 2114.3  (941.94)
Time Frame From Day 0 upto 4 days from PMA 40 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rhIGF-I/rhIGFBP-3 Standard of Care (Control)
Hide Arm/Group Description Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA. Participants in this control group do not received any treatment other than the standard care.
All-Cause Mortality
rhIGF-I/rhIGFBP-3 Standard of Care (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
rhIGF-I/rhIGFBP-3 Standard of Care (Control)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/61 (78.69%)      37/60 (61.67%)    
Blood and lymphatic system disorders     
Coagulation disorder neonatal * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Thrombocytopenia neonatal * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Cardiac disorders     
Bradycardia neonatal * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Cardiac hypertrophy * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Sick sinus syndrome * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Supraventricular tachycardia * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Congenital, familial and genetic disorders     
Patent ductus arteriosus * 1  13/61 (21.31%)  13 14/60 (23.33%)  14
Eye disorders     
Retinopathy of prematurity * 1  5/61 (8.20%)  6 2/60 (3.33%)  2
Gastrointestinal disorders     
Inguinal hernia * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Intestinal obstruction * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Intestinal perforation * 1  1/61 (1.64%)  1 3/60 (5.00%)  3
Intra-Abdominal haemorrhage * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Intussusception * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Meconium ileus * 1  2/61 (3.28%)  2 0/60 (0.00%)  0
Necrotising enterocolitis neonatal * 1  6/61 (9.84%)  6 3/60 (5.00%)  3
Volvulus * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
General disorders     
Generalised oedema * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Infections and infestations     
Citrobacter sepsis * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Enterococcal sepsis * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Escherichia sepsis * 1  1/61 (1.64%)  1 3/60 (5.00%)  3
Group b streptococcus neonatal sepsis * 1  1/61 (1.64%)  1 1/60 (1.67%)  1
Neonatal pneumonia * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Sepsis neonatal * 1  7/61 (11.48%)  8 1/60 (1.67%)  1
Serratia sepsis * 1  3/61 (4.92%)  3 0/60 (0.00%)  0
Staphylococcal sepsis * 1  9/61 (14.75%)  10 7/60 (11.67%)  9
Investigations     
Pco2 increased * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Metabolism and nutrition disorders     
Hyperammonaemia * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Hyperglycaemia * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Hypertriglyceridaemia * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Lactic acidosis * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Metabolic disorder * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Nervous system disorders     
Cerebellar haemorrhage * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Cerebral haemorrhage neonatal * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Convulsion neonatal * 1  2/61 (3.28%)  2 0/60 (0.00%)  0
Intraventricular haemorrhage neonatal * 1  7/61 (11.48%)  8 8/60 (13.33%)  8
Periventricular leukomalacia * 1  4/61 (6.56%)  4 1/60 (1.67%)  1
Renal and urinary disorders     
Renal failure neonatal * 1  3/61 (4.92%)  3 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary dysplasia * 1  0/61 (0.00%)  0 2/60 (3.33%)  2
Infantile apnoeic attack * 1  5/61 (8.20%)  6 3/60 (5.00%)  3
Neonatal aspiration * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Neonatal respiratory distress syndrome * 1  3/61 (4.92%)  3 3/60 (5.00%)  8
Neonatal respiratory failure * 1  7/61 (11.48%)  11 9/60 (15.00%)  13
Pleurisy * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Pneumothorax * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
Pulmonary haemorrhage * 1  1/61 (1.64%)  1 2/60 (3.33%)  2
Pulmonary hypertension * 1  2/61 (3.28%)  2 3/60 (5.00%)  3
Pulmonary interstitial emphysema syndrome * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Vascular disorders     
Neonatal hypotension * 1  2/61 (3.28%)  2 3/60 (5.00%)  3
Peripheral ischaemia * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Shock * 1  0/61 (0.00%)  0 1/60 (1.67%)  1
Vena cava thrombosis * 1  1/61 (1.64%)  1 0/60 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
rhIGF-I/rhIGFBP-3 Standard of Care (Control)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/61 (95.08%)      60/60 (100.00%)    
Blood and lymphatic system disorders     
Anaemia neonatal * 1  46/61 (75.41%)  210 44/60 (73.33%)  157
Coagulation disorder neonatal * 1  9/61 (14.75%)  10 8/60 (13.33%)  12
Neutropenia neonatal * 1  5/61 (8.20%)  5 0/60 (0.00%)  0
Thrombocytopenia neonatal * 1  12/61 (19.67%)  15 9/60 (15.00%)  13
Cardiac disorders     
Bradycardia neonatal * 1  13/61 (21.31%)  18 5/60 (8.33%)  6
Neonatal tachycardia * 1  4/61 (6.56%)  8 0/60 (0.00%)  0
Congenital, familial and genetic disorders     
Atrial septal defect * 1  6/61 (9.84%)  6 9/60 (15.00%)  10
Patent ductus arteriosus * 1  53/61 (86.89%)  67 45/60 (75.00%)  57
Eye disorders     
Retinopathy of prematurity * 1  39/61 (63.93%)  106 37/60 (61.67%)  89
Gastrointestinal disorders     
Abdominal distension * 1  5/61 (8.20%)  5 4/60 (6.67%)  4
Gastrooesophageal reflux disease * 1  7/61 (11.48%)  9 6/60 (10.00%)  6
Impaired gastric emptying * 1  1/61 (1.64%)  1 3/60 (5.00%)  3
Inguinal hernia * 1  9/61 (14.75%)  10 11/60 (18.33%)  11
Umbilical hernia * 1  3/61 (4.92%)  3 6/60 (10.00%)  6
Vomiting neonatal * 1  2/61 (3.28%)  2 3/60 (5.00%)  5
General disorders     
Generalised oedema * 1  9/61 (14.75%)  15 4/60 (6.67%)  5
Infusion site extravasation * 1  1/61 (1.64%)  1 3/60 (5.00%)  8
Oedema peripheral * 1  9/61 (14.75%)  11 1/60 (1.67%)  1
Hepatobiliary disorders     
Hyperbilirubinaemia neonatal * 1  12/61 (19.67%)  14 14/60 (23.33%)  18
Neonatal cholestasis * 1  2/61 (3.28%)  2 6/60 (10.00%)  6
Infections and infestations     
Fungal skin infection * 1  3/61 (4.92%)  6 3/60 (5.00%)  6
Neonatal pneumonia * 1  1/61 (1.64%)  1 3/60 (5.00%)  3
Pneumonia bacterial * 1  4/61 (6.56%)  4 5/60 (8.33%)  6
Rhinitis * 1  4/61 (6.56%)  5 3/60 (5.00%)  6
Sepsis neonatal * 1  16/61 (26.23%)  33 15/60 (25.00%)  29
Staphylococcal sepsis * 1  9/61 (14.75%)  14 12/60 (20.00%)  16
Investigations     
Blood alkaline phosphatase increased * 1  5/61 (8.20%)  6 6/60 (10.00%)  6
C-Reactive protein increased * 1  5/61 (8.20%)  6 4/60 (6.67%)  5
Metabolism and nutrition disorders     
Acidosis * 1  4/61 (6.56%)  5 8/60 (13.33%)  9
Feeding disorder neonatal * 1  1/61 (1.64%)  1 3/60 (5.00%)  4
Hypercalcaemia * 1  4/61 (6.56%)  5 4/60 (6.67%)  8
Hyperglycaemia * 1  24/61 (39.34%)  41 28/60 (46.67%)  55
Hypernatraemia * 1  6/61 (9.84%)  7 11/60 (18.33%)  13
Hypoalbuminaemia * 1  5/61 (8.20%)  6 4/60 (6.67%)  5
Hypocalcaemia * 1  8/61 (13.11%)  20 6/60 (10.00%)  6
Hypoglycaemia neonatal * 1  18/61 (29.51%)  22 19/60 (31.67%)  27
Hypokalaemia * 1  14/61 (22.95%)  24 11/60 (18.33%)  18
Hypophosphataemia * 1  2/61 (3.28%)  2 4/60 (6.67%)  5
Hypovolaemia * 1  1/61 (1.64%)  1 3/60 (5.00%)  4
Metabolic acidosis * 1  17/61 (27.87%)  43 22/60 (36.67%)  46
Neonatal hyponatraemia * 1  23/61 (37.70%)  43 22/60 (36.67%)  39
Musculoskeletal and connective tissue disorders     
Growth retardation * 1  1/61 (1.64%)  1 3/60 (5.00%)  3
Osteopenia * 1  6/61 (9.84%)  6 9/60 (15.00%)  9
Nervous system disorders     
Cerebral ventricle dilatation * 1  0/61 (0.00%)  0 3/60 (5.00%)  3
Convulsion neonatal * 1  3/61 (4.92%)  3 3/60 (5.00%)  3
Intraventricular haemorrhage neonatal * 1  11/61 (18.03%)  13 18/60 (30.00%)  19
Periventricular leukomalacia * 1  1/61 (1.64%)  1 3/60 (5.00%)  3
Pregnancy, puerperium and perinatal conditions     
Jaundice neonatal * 1  28/61 (45.90%)  34 30/60 (50.00%)  38
Poor weight gain neonatal * 1  3/61 (4.92%)  3 4/60 (6.67%)  4
Renal and urinary disorders     
Oliguria * 1  5/61 (8.20%)  5 3/60 (5.00%)  4
Reproductive system and breast disorders     
Oedema genital * 1  8/61 (13.11%)  9 1/60 (1.67%)  2
Respiratory, thoracic and mediastinal disorders     
Atelectasis neonatal * 1  3/61 (4.92%)  3 4/60 (6.67%)  4
Bronchopulmonary dysplasia * 1  34/61 (55.74%)  37 37/60 (61.67%)  42
Bronchospasm * 1  2/61 (3.28%)  2 8/60 (13.33%)  11
Hypocapnia * 1  2/61 (3.28%)  3 4/60 (6.67%)  5
Infantile apnoeic attack * 1  26/61 (42.62%)  42 16/60 (26.67%)  32
Neonatal hypoxia * 1  14/61 (22.95%)  17 13/60 (21.67%)  21
Neonatal respiratory acidosis * 1  10/61 (16.39%)  30 5/60 (8.33%)  11
Neonatal respiratory distress syndrome * 1  27/61 (44.26%)  31 32/60 (53.33%)  41
Neonatal respiratory failure * 1  9/61 (14.75%)  11 5/60 (8.33%)  5
Neonatal tachypnoea * 1  2/61 (3.28%)  2 4/60 (6.67%)  5
Pulmonary haemorrhage * 1  4/61 (6.56%)  4 0/60 (0.00%)  0
Pulmonary hypertension * 1  6/61 (9.84%)  6 9/60 (15.00%)  11
Pulmonary oedema neonatal * 1  6/61 (9.84%)  7 1/60 (1.67%)  1
Vascular disorders     
Neonatal hypotension * 1  23/61 (37.70%)  33 15/60 (25.00%)  27
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title: Study Physician
Organization: Shire
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01096784     History of Changes
Other Study ID Numbers: ROPP-2008-01
2007-007872-40 ( EudraCT Number )
First Submitted: March 9, 2010
First Posted: March 31, 2010
Results First Submitted: September 28, 2016
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017