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Trial record 1 of 1 for:    15174788 [PUBMED-IDS]
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Fluid Management in Transient Tachypnea of the Newborn

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ClinicalTrials.gov Identifier: NCT01225029
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Transient Tachypnea of the Newborn
Intervention Other: Amount of total fluids
Enrollment 64
Recruitment Details Patients were recruited at our urban tertiary care center from August 1, 2008 through September 2, 2010. Patients were withdrawn from the study protocol if any respiratory diagnosis other than TTN was made.
Pre-assignment Details 73 patients met enrollment criteria, and the parents of 67 eligible neonates agreed to participate. 34 were assigned to standard-of-care fluid management and 33 were assigned to the restricted fluid protocol. 2 patients from the standard fluid group and 1 patient from the restricted fluid group were withdrawn for a non-TTN respiratory diagnosis.
Arm/Group Title Standard Fluids Restricted Fluids
Hide Arm/Group Description Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved. Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Period Title: Overall Study
Started 32 32
Completed 32 32
Not Completed 0 0
Arm/Group Title Standard Fluids Restricted Fluids Total
Hide Arm/Group Description Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved. Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved Total of all reporting groups
Overall Number of Baseline Participants 32 32 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 32 participants 32 participants 64 participants
35.8  (1.6) 36.4  (1.5) 36.1  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Female
15
  46.9%
16
  50.0%
31
  48.4%
Male
17
  53.1%
16
  50.0%
33
  51.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   6.3%
3
   9.4%
5
   7.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  25.0%
9
  28.1%
17
  26.6%
White
21
  65.6%
20
  62.5%
41
  64.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.1%
0
   0.0%
1
   1.6%
1.Primary Outcome
Title Duration of Respiratory Support
Hide Description [Not Specified]
Time Frame every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluids Restricted Fluids
Hide Arm/Group Description:
Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Overall Number of Participants Analyzed 32 32
Median (Inter-Quartile Range)
Unit of Measure: hours
45
(26 to 85)
42
(26 to 69)
2.Secondary Outcome
Title Duration of ICU Admission
Hide Description [Not Specified]
Time Frame every day until discharge, an average of approximately 8 days and a maximum of 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluids Restricted Fluids
Hide Arm/Group Description:
Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Overall Number of Participants Analyzed 32 32
Mean (Inter-Quartile Range)
Unit of Measure: calendar days
8
(5 to 12)
7
(4 to 10)
3.Secondary Outcome
Title Time to First Enteral Feed
Hide Description [Not Specified]
Time Frame hour until first enteral feed achieved, an average of approximately 40 hours and a maximum of 100 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Fluids Restricted Fluids
Hide Arm/Group Description:
Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Overall Number of Participants Analyzed 32 32
Mean (Inter-Quartile Range)
Unit of Measure: hours
31
(21 to 51)
35
(23 to 44)
Time Frame Study safety was assessed daily for all enrolled patients. Predetermined indicators of dehydration including daily weight, daily urine output, and daily serum sodium, blood urea nitrogen (BUN), creatinine, glucose, and bilirubin level were monitored.
Adverse Event Reporting Description No patient enrolled in the study experienced an adverse event or unsafe fluid or glycemic balance due to the study protocol.
 
Arm/Group Title Standard Fluids Restricted Fluids
Hide Arm/Group Description Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved. Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
All-Cause Mortality
Standard Fluids Restricted Fluids
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Fluids Restricted Fluids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Fluids Restricted Fluids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
As a small, single center study, our results may not be fully generalizable to the TTN patient population in all hospital types on a national level.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Annemarie Stroustrup
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-6186
Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01225029     History of Changes
Other Study ID Numbers: GCO 07-1069
First Submitted: October 18, 2010
First Posted: October 20, 2010
Results First Submitted: September 24, 2013
Results First Posted: November 28, 2013
Last Update Posted: November 28, 2013