Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn, Persistent Pulmonary Hypertension
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREprone positioning
newborn babies in prone positioning
PROCEDURESupine
newborn babies in supine positioning
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Countries
United States
Outcome results
None listed