CompletedNot Applicable

Fluid Restriction in Respiratory Distress of the Newborn

United States65 participantsStarted 2017-03-01

Plain-language 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.

Who can participate

Age range

12 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time from birth to first oral feeding

Timeframe: every 24 hours for up to 168 hours

Trial details

NCT IDNCT03120585

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-24

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Newborn trials