Fluid Restriction in Respiratory Distress of the Newborn

Sponsor

University of Oklahoma (Other)

Overall Status

Completed

CT.gov ID

NCT03120585

Collaborator

Icahn School of Medicine at Mount Sinai (Other), Universidad Abierta Interamericana (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

32.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Newborn	Other: Fluid Management Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Jul 24, 2020

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Time from birth to first oral feeding [every 24 hours for up to 168 hours]
Total Hours until first oral feeding

Secondary Outcome Measures

Duration of Respiratory Support [every 3 hours for up to 168 hours]
Total hours of Respiratory Support
Total Duration of NICU stay [every 24 hours up to 12 weeks]
Length of Stay in the NICU

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Hours

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029-5674
2	Comanche county Memorial hospital	Lawton	Oklahoma	United States	73501

Sponsors and Collaborators

University of Oklahoma
Icahn School of Medicine at Mount Sinai
Universidad Abierta Interamericana

Investigators

Study Director: Abhishek Makkar, MD, University of Oklahoma HSC

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT03120585

Other Study ID Numbers:

4688

First Posted:

Apr 19, 2017

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Oklahoma

Respiratory Distress Syndrome, Newborn

fluid restriction

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Jun 30, 2021