Effect of Supine or Prone Position After Caesarean Birth
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|ClinicalTrials.gov Identifier: NCT01310153|
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : March 8, 2011
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.
The investigators hypothesize 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.
The investigators will compare 1033 term babies divided by randomization into two groups prone and supine. The investigators will check for incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Transitory Tachypnea of Newborn Delayed Transition of the Newborn Persistent Pulmonary Hypertension||Procedure: prone positioning||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Official Title:||Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth|
|Study Start Date :||September 2006|
|Study Completion Date :||February 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310153
|United States, New York|
|Jack D. Weiler Hospital of the Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Orna Rosen, MD||Montefiore Medical Center|