Fluid Restriction in Respiratory Distress of the Newborn

Multicenter Randomized Controlled Trial Of Restrictive Fluid Management For Respiratory Distress in the Newborn Period

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Other: Fluid Management Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029-5674
      • Icahn School of Medicine at Mount Sinai
  • Oklahoma
    • Lawton, Oklahoma, United States, 73501
      • Comanche County Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluid Management Intervention; 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)	Other: Fluid Management Intervention; 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 .
No Intervention: Control Group; Infants with respiratory distress will receive standard of care fluid management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from birth to first oral feeding	Total Hours until first oral feeding	every 24 hours for up to 168 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Respiratory Support	Total hours of Respiratory Support	every 3 hours for up to 168 hours
Total Duration of NICU stay	Length of Stay in the NICU	every 24 hours up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Icahn School of Medicine at Mount Sinai; Universidad Abierta Interamericana
• Investigators: Study Director: Abhishek Makkar, MD, University of Oklahoma HSC

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): July 24, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: April 15, 2017
• First Posted (Actual): April 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: fluid restriction; Respiratory Distress Syndrome, Newborn
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 4688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No