Fluid Restriction in Respiratory Distress of the Newborn

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120585
• Other study ID #: 4688
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 31, 2021
• Est. primary completion date: July 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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 .

Locations

Country	Name	City	State
United States	Comanche county Memorial hospital	Lawton	Oklahoma
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Oklahoma	Icahn School of Medicine at Mount Sinai, Universidad Abierta Interamericana

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2014;(12):CD000503. doi: 10.1002/14651858.CD000503.pub3. Epub 2014 Dec 4. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from birth to first oral feeding	Total Hours until first oral feeding	every 24 hours for up to 168 hours
Secondary	Duration of Respiratory Support	Total hours of Respiratory Support	every 3 hours for up to 168 hours
Secondary	Total Duration of NICU stay	Length of Stay in the NICU	every 24 hours up to 12 weeks