Status:
COMPLETED
Fluid Management in Transient Tachypnea of the Newborn
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Transient Tachypnea of the Newborn
Eligibility:
All Genders
Up to 24 years
Phase:
NA
Brief 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...
Detailed Description
1. Project Abstract Transient tachypnea of the newborn (TTN) is a self-limited respiratory distress syndrome of term and late pre-term neonates.1 Respiratory distress attributed to TTN requires manage...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01225029
Start Date
June 1 2008
End Date
September 1 2010
Last Update
November 28 2013
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029