CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Amount of total fluidsother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01225029
NCT01225029N/ACompleted

A Randomized Controlled Trial of Fluid Management in Transient Tachypnea of the Newborn

Icahn School of Medicine at Mount Sinai·interventional·Posted Oct 20, 2010·Updated Nov 28, 2013

In Brief

A clinical study evaluating Amount of total fluids for Transient Tachypnea of the Newborn. Completed, enrolled 64 participants across 1 site.

Detailed Summary

Transient tachypnea of the newborn (TTN) is a diagnosis given to infants born between 34 and 42 weeks gestation who develop difficulty breathing during the first days of life when no specific cause of the breathing difficulty can be identified. Little is known about why some babies develop TTN, and there have not been many formal studies of the best way to take care of babies with this disease. Babies with TTN get better on their own within three to five days after birth, but may require extra oxygen to breath well. Most physicians believe that the symptoms of TTN are related to poor clearance of fluid from the newborn's lungs. Babies with TTN have extra fluid visible on chest x-ray. Diuretics, medicines that can help clear extra lung fluid in adults and in babies with extra lung fluid for other reasons, do not to help babies with TTN. Babies with TTN need intravenous fluids to be healthy because they breathe too fast to be able to eat. Breastfed babies only get a very small amount of fluid in the first few days of life, as it normally takes several days for a new mother to begin producing breastmilk. No one has yet examined whether giving babies with TTN an amount of fluid similar to the small amount they would receive if they could breastfeed would help them recover from TTN faster. In this study, the investigators compare whether giving newborns "standard" intravenous fluid or amounts of intravenous fluid more close to what a breastfed baby would receive speeds recovery in newborns with TTN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2010
Enrollment StartJun 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.7 years ago

Interventions

Amount of total fluidsother

Term neonates receive either total fluids of 60 mL/kg/day (standard) or 40 mL/kg/day (restricted) on day of life (DOL) 1. Preterm neonates receive total fluids of 80 mL/kg/day (standard) or 60 mL/kg/day (restricted) on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.