Clinical trial NCT00139256: Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Official title: Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: Glucocorticoid
Antepartum Betamethasone Treatment
Elective Cesarean Section
Respiratory Distress in Infants
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-08-31
Enrollment: 67
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (\>34 and \<40 weeks of gestation) who are scheduled to undergo a planned Cesarean section. The study design is to determine the efficacy and safety of betamethasone in the prevention of breathing problems commonly seen in this population.

In infants born by elective Cesarean section, it is hypothesized that antenatal betamethasone treatment will reduce the risk of neonatal intensive care unit (NICU) admission from 11% to 8% and/or oxygen therapy +/- positive pressure ventilation (PPV) for \>30 minutes from 4.5% to 2.5%.

Detailed description: The purpose of this pilot study is to determine if antepartum betamethasone given to mothers undergoing elective cesarean section (ECS) delivery at term or near term gestation (\>34 and \< 40 weeks of gestation) is safe and feasible in reducing neonatal respiratory morbidity and the related admissions to neonatal intensive care units (NICU).

The data from this pilot study will be used to support a NIH application for a multicenter randomized trial to determine, if compared to placebo treatment, antenatal betamethasone initiated 2-7 days prior to an ECS results in decreased occurrence of respiratory morbidity and NICU admissions in the newborn.

The multicenter protocol was recently reviewed by the NICHD network for clinical trial. The reviewers were enthusiastic about the scientific merit and public health importance of the study but asked for a pilot study to determine feasibility before launching the national trial. Given the rise in the rate of CS deliveries, we project substantial health cost savings from this preventive strategy if it were found to be successful in reducing neonatal morbidity.

Eligibility criteria: Inclusion Criteria:

* Pregnant women \>/= 34 weeks gestation scheduled to undergo operative delivery within 48-72 hours after study enrollment

Exclusion Criteria:

* Known contraindication to the use of betamethasone in the mother
* Known lethal or non-lethal congenital anomaly diagnosed antenatally
* Spontaneous labor
* Premature rupture of membranes

Primary outcomes:
measure: The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University affiliated newborn intensive care units
state: Georgia
Study officials:
affiliation: Emory University Department of Pediatrics, Division of Neonatology
name: Lucky Jain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sotiriadis A, McGoldrick E, Makrydimas G, Papatheodorou S, Ioannidis JP, Stewart F, Parker R. Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes. Cochrane Database Syst Rev. 2021 Dec 22;12(12):CD006614. doi: 10.1002/14651858.CD006614.pub4.