Fluid Restriction in Respiratory Distress of the Newborn

Completed · Not applicable

Conditions studied: Respiratory Distress Syndrome, Newborn

In brief

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.

Key facts

Study ID

NCT03120585

Run by

University of Oklahoma

People needed

65

Starts

2017-03-01

Expected to finish

2021-03-31

Last updated by the study team

2021-06-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Comanche county Memorial hospital — Lawton, Oklahoma, United States

Full record on ClinicalTrials.gov

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