Fluid Management in Transient Tachypnea of the Newborn

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01225029
• Date of registration: 18/10/2010
• Primary sponsor: Mount Sinai School of Medicine
• Public title: Fluid Management in Transient Tachypnea of the Newborn
• Scientific title: A Randomized Controlled Trial of Fluid Management in Transient Tachypnea of the Newborn
• Date of first enrolment: June 2008
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01225029
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Annemarie Stroustrup, MD, MPH
• Affiliation: Mount Sinai School of Medicine

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 24 Hours
Gender: Both

Health Condition(s) or Problem(s) studied

Transient Tachypnea of the Newborn

Intervention(s)

Other: Amount of total fluids

Primary Outcome(s)

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]

Secondary Outcome(s)

Duration of ICU admission [Time Frame: every day until discharge, an average of approximately 8 days and a maximum of 12 days]

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]

Secondary ID(s)

07-1069

Source(s) of Monetary Support

Please refer to primary and secondary sponsors