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Analgesic Efficacy of Different Doses of Sucrose During Blood Sampling in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02859376
Recruitment Status : Unknown
Verified August 2016 by Teresa Mion, University Hospital Padova.
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Teresa Mion, University Hospital Padova

Brief Summary:
The objective of this trial is to compare the analgesic effect of a single dose of oral sucrose 24% administered two minutes before a blood sampling (either heel prick or vascular puncture) versus multiple doses of oral sucrose 24% administered two minutes before and during the procedure in a population of preterm newborns of Gestational Age ≤ 36+6 weeks hospitalized in Neonatal Intensive Care Unit, using neonatal pain scales (Premature Infant Pain Profile (PIPP), Face, Legs, Activity, Cry, Consolability (FLACC) and indirect Visual Analogue Scale (VAS)) and Skin Conductance (SC) measurement (Pain Monitor).

Condition or disease Intervention/treatment Phase
Pain Dietary Supplement: sucrose 24% Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Efficacy of Different Doses of Sucrose During Blood Sampling in Preterm Infants: Prospective, Randomized, Controlled, Double Blind, Clinical Trial
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arm Intervention/treatment
Active Comparator: sucrose24% 2 minutes before
sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE the skin breaking procedure
Dietary Supplement: sucrose 24%
Premature neonates undergoing blood samples through skin breaking procedures, meeting inclusion criteria, will be randomized as soon as the doctor decision to drown the blood is made, to either sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE the skin breaking procedure or sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE and DURING the skin breaking procedure, according to a computer generated randomization list.

Experimental: sucrose24% 2minutes before and during
sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE and DURING the skin breaking procedure
Dietary Supplement: sucrose 24%
Premature neonates undergoing blood samples through skin breaking procedures, meeting inclusion criteria, will be randomized as soon as the doctor decision to drown the blood is made, to either sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE the skin breaking procedure or sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE and DURING the skin breaking procedure, according to a computer generated randomization list.




Primary Outcome Measures :
  1. Change of analgesic efficacy Premature Infant Pain Profile (PIPP) [ Time Frame: 2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture ]
    The primary outcome of this study will be to evaluate the analgesic efficacy of sucrose 24% administration (single versus multiple doses) during blood sampling using Premature Infant Pain Profile (PIPP).


Secondary Outcome Measures :
  1. Change of analgesic efficacy Face, Legs, Activity, Cry, Consolability (FLACC) [ Time Frame: at 30 and 120 seconds after the skin puncture ]
    The analgesic efficacy of sucrose 24% administration (single Vs multiple doses) during blood sampling using Face, Legs, Activity, Cry, Consolability (FLACC)

  2. Change of analgesic efficacy Visual Analogue Scale (VAS) [ Time Frame: at 30 and 120 seconds after the skin puncture ]
    The analgesic efficacy of sucrose 24% administration (single Vs multiple doses) during blood sampling using indirect Visual Analogue Scale (VAS).

  3. Change of analgesic efficacy Pain Monitor (skin electrical conductance) [ Time Frame: 2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture ]
    The analgesic efficacy of sucrose 24% administration (single Vs multiple doses) during blood sampling using Pain Monitor (skin electrical conductance)

  4. Pain evaluation during heel prick Vs vascular puncture PIPP [ Time Frame: Through study completion, an average of 1 year ]
    Pain evaluation during heel prick Vs vascular puncture will be performed using PIPP scale

  5. Pain evaluation during heel prick Vs vascular puncture FLACC [ Time Frame: Through study completion, an average of 1 year ]
    Pain evaluation during heel prick Vs vascular puncture will be performed using FLACC scale

  6. Pain evaluation during heel prick Vs vascular puncture VAS [ Time Frame: Through study completion, an average of 1 year ]
    Pain evaluation during heel prick Vs vascular puncture will be performed using VAS scale

  7. Pain evaluation during heel prick Vs vascular puncture Pain Monitor (skin electrical conductance) [ Time Frame: Through study completion, an average of 1 year ]
    Pain evaluation during heel prick Vs vascular puncture will be performed using Pain Monitor (skin electrical conductance)

  8. Intra--hospital outcome Mechanical Ventilation (MV) duration [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome MV duration

  9. Intra--hospital outcome non-Invasive MV (nIMV) duration [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome nIMV duration

  10. Intra--hospital outcome oxygen dependence duration [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome oxygen dependence

  11. Intra--hospital outcome rate of Bronchopulmonary Dysplasia (BPD) [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome rate of BPD

  12. Intra--hospital outcome rate of Pneumothorax (PNX) [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome rate of PNX

  13. Intra--hospital outcome rate of Patent ductus arteriosus (PDA) [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome rate of PDA

  14. Intra--hospital outcome incidence Intraventricular hemorrhage (IVH)/ Periventricular leukomalacia (PVL) [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome incidence of IVH/PVL

  15. Intra--hospital outcome incidence death within 28 days of life [ Time Frame: within 28 days of life ]
    Intra--hospital outcome incidence of death within 28 days of life

  16. Intra--hospital outcome incidence hydrocephalus [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome incidence of hydrocephalus

  17. Intra--hospital outcome time to Full Enteral Feeding (FEF) [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome time to FEF

  18. Intra--hospital outcome rate of Necrotizing Enterocolitis (NEC) [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome rate of NEC (all stages according to the modified Bell's criteria)

  19. Intra--hospital outcome rate of proved sepsis [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome rate of proved sepsis

  20. Intra--hospital outcome rate of suspected sepsis [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome rate of suspected sepsis

  21. Intra--hospital outcome rate of Retinopathy of Prematurity (ROP) [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome rate of ROP

  22. Intra--hospital outcome time to regain birth weight [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome time to regain birth weight

  23. Intra--hospital outcome hospitalization length [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome hospitalization length

  24. Intra--hospital outcome incidence hospital discharge without major morbidities [ Time Frame: Through study completion, an average of 1 year ]
    Intra--hospital outcome incidence of hospital discharge without major morbidities

  25. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Through study completion till patient discharge, an average of 1 year ]
    Safety [achieved by monitoring and registering adverse events (AEs), serious adverse events (SAEs) even those unexpected (SUSARs), and measuring vital signs]



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm neonates with gestational age ranging from 23+ 0 to 36+ 6 weeks
  • undergoing blood sampling (either heel prick or vascular puncture)
  • age ≤ 40 week GA + 28 days at the time of blood sampling
  • parental written informed consent for participation in the study must be obtained

Exclusion Criteria:

  • Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH < 7.0
  • Known genetic or chromosomal disorders
  • Myopathies and neuropathies interfering with pain assessment by pain scales
  • Sedation
  • Presence of central catheter allowing blood sampling without skin breaking
  • Other painful procedure less than 2 hours before blood sampling
  • Physiological instability (more than 6 episodes of bradycardia and/or apnea per day)
  • Maternal drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859376


Contacts
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Contact: Teresa Mion, MD +39 049 8213547 tritrimi@gmail.com

Locations
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Italy
University Hospital of Padova Recruiting
Padova, Italy, 35128
Contact: Paola Lago, MD    +39 049 821 3545    paola.lago9@gmail.com   
Contact: Teresa Mion, MD    +39 049 821 3545    tritrimi@gmail.com   
Sponsors and Collaborators
University Hospital Padova
Investigators
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Principal Investigator: Paola Lago, MD

Publications:
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Responsible Party: Teresa Mion, MD, University Hospital Padova
ClinicalTrials.gov Identifier: NCT02859376     History of Changes
Other Study ID Numbers: AOP0066025
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Teresa Mion, University Hospital Padova:
Preterm infants
Pain
Sucrose

Additional relevant MeSH terms:
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Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs