Effect of Supine or Prone Position After Caesarean Birth

Transient Tachypnea of the Newborn Clinical Trial

Official title:

Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310153
• Other study ID #: 06-09-409
• Status: Completed
• Phase: N/A
• Start date: September 2006
• Est. completion date: February 2009

Study information

• Verified date: August 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by Caesarean birth.

Description:

This study hypothesizes that when the infant is prone they will have postural drainage, better dorsal lung expansion, less vagal response from suctioning and less agitation secondary to the righting reflex.

This study will compare 1033 term babies divided by randomization into two groups prone and supine. During the study, care givers will monitor and record incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any woman not in labor who are undergoing elective Cesarean birth at term, 37 to 41 completed weeks gestation.

Exclusion Criteria:

• any woman with prior rupture of membranes

• diabetes mellitus, gestational diabetes,

• any woman receiving sedation

• using medication such as Demerol, magnesium sulfate or general anesthesia

• any woman who has a known drug history

• any known macrosomia

• known congenital anomalies or meconium stained fluid

• any woman with illnesses such as maternal fever, chorioamnionitis, severe neonatal distress

• any woman with compromised infant at delivery

• oligohydramnios

• history of antenatal steroids.

Related Conditions & MeSH terms

• Delayed Transition of the Newborn
• Hypertension, Pulmonary
• Persistent Pulmonary Hypertension
• Respiratory Distress
• Tachypnea
• Transient Tachypnea of the Newborn

Intervention

Procedure:
• prone positioning
newborn babies in prone positioning
• Supine
newborn babies in supine positioning

Locations

Country	Name	City	State
United States	Jack D. Weiler Hospital of the Albert Einstein College of Medicine	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States,