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Search / Trial NCT01225029

Fluid Management in Transient Tachypnea of the Newborn

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Oct 19, 2010

Trial Information

Current as of May 20, 2025

Completed

Keywords

Premature Birth Late Preterm Birth Respiratory Distress Of The Newborn Transient Tachypnea Of The Newborn

ClinConnect Summary

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 management of otherwise healthy infants in an intensive care setting, thus increasing cost, and often length, of hospitalization as well as decreasing opportunity for parent-child bonding in the first days of life. Although hundreds of thousands of children are treated for TTN every year (over 250 in the Mount Sinai NICU in 2005 alone), little data underlie standard of care medical management. We are...

Gender

ALL

Eligibility 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.

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Annemarie Stroustrup, MD, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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