NCT03120585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

3.4 years

First QC Date

September 8, 2015

Last Update Submit

June 29, 2021

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Respiratory Distress Syndrome, Newbornfluid restriction

Outcome Measures

Primary Outcomes (1)

  • Time from birth to first oral feeding

    Total Hours until first oral feeding

    every 24 hours for up to 168 hours

Secondary Outcomes (2)

  • Duration of Respiratory Support

    every 3 hours for up to 168 hours

  • Total Duration of NICU stay

    every 24 hours up to 12 weeks

Study Arms (2)

Fluid Management Intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Fluid Management InterventionOTHER

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 .

Fluid Management Intervention

Eligibility Criteria

AgeUp to 12 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Neonates with a genetic abnormality or congenital anatomic anomaly
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-5674, United States

Location

Comanche county Memorial hospital

Lawton, Oklahoma, 73501, United States

Location

Related Publications (2)

  • 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.

    PMID: 25473815BACKGROUND

  • 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.

    PMID: 21839467BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Abhishek Makkar, MD

    University of Oklahoma HSC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2015

First Posted

April 19, 2017

Study Start

March 1, 2017

Primary Completion

July 24, 2020

Study Completion

March 31, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Locations

US(2)