Fluid Management in Transient Tachypnea of the Newborn
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Fluid Management in Transient Tachypnea of the Newborn|
- Duration of Respiratory Support [ Time Frame: every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours ] [ Designated as safety issue: No ]
- Duration of ICU Admission [ Time Frame: every day until discharge, an average of approximately 8 days and a maximum of 12 days ] [ Designated as safety issue: No ]
- Time to First Enteral Feed [ Time Frame: hour until first enteral feed achieved, an average of approximately 40 hours and a maximum of 100 hours ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
No Intervention: Standard Fluids
Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Preterm neonates receive total fluids of 80 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
Experimental: Restricted Fluids
Term neonates receive total fluids of 40 mL/kg/day on day of life (DOL) 1. Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Other: Amount of total fluids
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01225029
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Annemarie Stroustrup, MD, MPH||Icahn School of Medicine at Mount Sinai|