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Fluid Management in Transient Tachypnea of the Newborn

This study has been completed.
Sponsor:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01225029
First received: October 18, 2010
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Transient Tachypnea of the Newborn
 Other: Amount of total fluids

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: June 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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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  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gestational age at birth 34 and 42 weeks of gestation
  2. Admission to the Mount Sinai NICU during the first 24 hours of life
  3. Diagnosis during the first 24 hours of life of transient tachypnea of the newborn

Exclusion criteria:

  1. Gestational age at birth less than 34 weeks or greater than 42 weeks at birth
  2. No diagnosis of TTN made in the first 24 hours of life
  3. Additional infant diagnosis of major cardiac disease
  4. Additional infant diagnosis of major pulmonary disease other than TTN
  5. Additional infant diagnosis of meconium aspiration syndrome
  6. Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal period
  7. Additional infant diagnosis of infectious disease process potentially affecting respiratory status in the neonatal period
  8. Observation of thick meconium in the amniotic fluid at delivery.
  9. Maternal diagnosis of chorioamnionitis or other infection of the uterus or fallopian tubes pre- or peri-partum.

Criteria for removal from the study:

(a) Additional infant diagnosis of major cardiac, pulmonary, or other disease process potentially affecting respiratory status in the neonatal period (i.e., infection, meconium aspiration, pneumothorax, congenital anomaly) present during the study period. (b) Positive test of infection (e.g. blood, CSF, or urine culture; viral DFA; microscopy) drawn from infant at any point during the study period. (c) Maternal diagnosis of chorioamnionitis or other infection of the uterus or fallopian tubes at any point during hospital stay. (d) Objective clinical signs of dehydration: (i) Newborn urine output less than 2 mL/kg/hr over a twelve hour period at any point during the study period. (ii) Newborn serum sodium less than 130 mEq/L or greater than 150 mEq/L at any point during the study period. (iii) Newborn weight loss >10% of birth weight at any point during the study period.

(e) Newborn blood glucose by point-of-care testing of less than 40 mg/dL at any point during the study period. (f) Administration of exogenous surfactant at any point during the study period.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225029

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Annemarie Stroustrup, MD, MPH Mount Sinai School of Medicine
  More Information

Additional Information:
Information about the disorder  This link exits the ClinicalTrials.gov site
MSSM clinical trials web-site posting  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Annemarie Stroustrup, MD, MPH, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01225029     History of Changes
Other Study ID Numbers: 07-1069
Study First Received: October 18, 2010
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
premature birth
late preterm birth
respiratory distress of the newborn
Transient tachypnea of the newborn

ClinicalTrials.gov processed this record on June 13, 2013