N/A N=64 Randomized Treatment

Fluid Management in Transient Tachypnea of the Newborn

Transient Tachypnea of the Newborn

Bottom Line

View on ClinicalTrials.gov: NCT01225029 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcome: Primary: Duration of Respiratory Support — 45; 42 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Amount of total fluids (Other)
Age: Pediatric
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Respiratory Support	45; 42	—
SECONDARY Duration of ICU Admission	8; 7	—
SECONDARY Time to First Enteral Feed	31; 35	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion criteria

Gestational age at birth less than 34 weeks or greater than 42 weeks at birth
No diagnosis of TTN made in the first 24 hours of life
Additional infant diagnosis of major cardiac disease
Additional infant diagnosis of major pulmonary disease other than TTN
Additional infant diagnosis of meconium aspiration syndrome
Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal period
Additional infant diagnosis of infectious disease process potentially affecting respiratory status in the neonatal period
Observation of thick meconium in the amniotic fluid at delivery.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01225029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.