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Fluid Restriction in Respiratory Distress of the Newborn

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid Management Intervention
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring Respiratory Distress Syndrome, Newborn, fluid restriction

Eligibility Criteria

undefined - 12 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neonates born between 34-0/7 and 41-6/7 weeks gestational age (GA) at birth with primary pulmonary disease of the newborn including Transient Tachypnea of the Newborn (TTN), Respiratory Distress Syndrome (RDS), air leak syndrome, pneumonia, or meconium aspiration syndrome in the first 12 hours of life will be eligible for inclusion in this study.
  • Those neonates who are intubated for administration of exogenous surfactant but who are immediately extubated to non-invasive respiratory support after surfactant administration will remain eligible for study inclusion.

Exclusion Criteria:

  • Neonates with a genetic abnormality or congenital anatomic anomaly

Subsequent Study Exclusion resulting in removal from study:

  • Neonates who subsequently undergo endotracheal intubation and mechanical ventilation for refractory respiratory distress
  • Neonates with hypoglycemia or clinical evidence of dehydration or volume depletion requiring fluid bolus
  • Infants that are transported out of the participating site prior to study endpoint.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai
  • Comanche county Memorial hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fluid Management Intervention

Control Group

Arm Description

Restricting IV fluids to infants with respiratory distress to mimic fluid intake of normal healthy breast fed infants (less fluid that current standard of care)

Infants with respiratory distress will receive standard of care fluid management.

Outcomes

Primary Outcome Measures

Time from birth to first oral feeding
Total Hours until first oral feeding

Secondary Outcome Measures

Duration of Respiratory Support
Total hours of Respiratory Support
Total Duration of NICU stay
Length of Stay in the NICU

Full Information

First Posted
September 8, 2015
Last Updated
June 29, 2021
Sponsor
University of Oklahoma
Collaborators
Icahn School of Medicine at Mount Sinai, Universidad Abierta Interamericana
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1. Study Identification

Unique Protocol Identification Number
NCT03120585
Brief Title
Fluid Restriction in Respiratory Distress of the Newborn
Official Title
Multicenter Randomized Controlled Trial Of Restrictive Fluid Management For Respiratory Distress in the Newborn Period
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
July 24, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Icahn School of Medicine at Mount Sinai, Universidad Abierta Interamericana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The object of this study is to determine the best way to care for infants with respiratory distress. The investigators are testing a method of feeding fluids to infants with respiratory distress in amounts similar to what healthy breastfed babies eat when they are feeding on demand, and comparing this method to the current standard of care for feeding fluids to infants with respiratory distress. These methods of feeding fluids to the study infants will continue until the infants are able to feed normally by mouth. The study will include about 400 infants across five sites in the United States, Chile and Argentina.
Detailed Description
Infants with respiratory distress syndrome will be enrolled within the first twelve hours of life, and randomly assigned to one of two groups: the first group will receive the interventional fluid management method, and the second (the control group) will receive the current standard of care for fluid management. To standardize respiratory care across all five study sites, a computer-based algorithm for respiratory support management based on objective markers of respiratory distress will guide clinician management decisions. However, each infant's medical team will make all final decisions on respiratory treatment and IV fluid management. Any study infant who experiences dehydration and/or low blood sugar during the course of the study will be removed from the study and be treated for the condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
Respiratory Distress Syndrome, Newborn, fluid restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluid Management Intervention
Arm Type
Experimental
Arm Description
Restricting IV fluids to infants with respiratory distress to mimic fluid intake of normal healthy breast fed infants (less fluid that current standard of care)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Infants with respiratory distress will receive standard of care fluid management.
Intervention Type
Other
Intervention Name(s)
Fluid Management Intervention
Intervention Description
Fluid management intervention is fluid restriction to 60 mL/kg/day on Day of Life (DOL) 1 for preterm and 40 mL/kg/day on DOL 1 for term neonates, calculated as total of IV and enteral fluid intake. Infants randomized to low infusion with be placed on 10% dextrose and the Infant will be monitored by obtaining serum glucose levels by point of care testing. Glucose infusion rates (GIR) would be calculated to the corresponding serum glucose and recorded. After 24 hours, infusion rate will be increased to 60ml/kg/d providing minimum GIR >4mg/kg/d. . Total fluid intake will be increased by 20 mL/kg/day until 150 mL/kg/day .
Primary Outcome Measure Information:
Title
Time from birth to first oral feeding
Description
Total Hours until first oral feeding
Time Frame
every 24 hours for up to 168 hours
Secondary Outcome Measure Information:
Title
Duration of Respiratory Support
Description
Total hours of Respiratory Support
Time Frame
every 3 hours for up to 168 hours
Title
Total Duration of NICU stay
Description
Length of Stay in the NICU
Time Frame
every 24 hours up to 12 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neonates born between 34-0/7 and 41-6/7 weeks gestational age (GA) at birth with primary pulmonary disease of the newborn including Transient Tachypnea of the Newborn (TTN), Respiratory Distress Syndrome (RDS), air leak syndrome, pneumonia, or meconium aspiration syndrome in the first 12 hours of life will be eligible for inclusion in this study. Those neonates who are intubated for administration of exogenous surfactant but who are immediately extubated to non-invasive respiratory support after surfactant administration will remain eligible for study inclusion. Exclusion Criteria: Neonates with a genetic abnormality or congenital anatomic anomaly Subsequent Study Exclusion resulting in removal from study: Neonates who subsequently undergo endotracheal intubation and mechanical ventilation for refractory respiratory distress Neonates with hypoglycemia or clinical evidence of dehydration or volume depletion requiring fluid bolus Infants that are transported out of the participating site prior to study endpoint.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhishek Makkar, MD
Organizational Affiliation
University of Oklahoma HSC
Official's Role
Study Director
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-5674
Country
United States
Facility Name
Comanche county Memorial hospital
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73501
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25473815
Citation
Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2014;2014(12):CD000503. doi: 10.1002/14651858.CD000503.pub3. Epub 2014 Dec 4.
Results Reference
background
PubMed Identifier
21839467
Citation
Stroustrup A, Trasande L, Holzman IR. Randomized controlled trial of restrictive fluid management in transient tachypnea of the newborn. J Pediatr. 2012 Jan;160(1):38-43.e1. doi: 10.1016/j.jpeds.2011.06.027. Epub 2011 Aug 11.
Results Reference
background

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Fluid Restriction in Respiratory Distress of the Newborn

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