Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates

Stopped early · Not applicable

Conditions studied: Safety Issues

In brief

Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU). Skin-to-skin contact (SSC) is a standard of care in many units to aid in post-natal transitioning. Current guidelines published by the Neonatal Resuscitation Program (NRP) and American Academy of Pediatrics (AAP) recommend only "vigorous, term" neonates initiate immediate SSC. There is no published data regarding safety or guidelines relating to late-preterm neonates and immediate SSC. Therefore, the investigators hypothesize that post-natal transitioning after immediate SSC within the first hours after birth will be no worse for vigorous, singleton 35 0/7 to 36 6/7 week neonates compared to those who transition to SSC after an initial period of 20 minutes observation under the radiant warmer.

Key facts

Study ID

NCT03585192

Run by

University Hospitals Cleveland Medical Center

People needed

47

Starts

2017-11-08

Expected to finish

2019-05-01

Last updated by the study team

2019-05-03

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Singletons born 35 0/7 to 36 6/7 weeks GA via vaginal delivery
• Vigorous - crying, good respiratory effort, good tone
• No major congenital malformation

You may not qualify if…

• Neonates born < 35 weeks GA
• Non-vigorous or needing resuscitation soon after birth
• Known major congenital malformation
• Maternal sedation or if clinically unstable per Labor \& Delivery team

Where it is running

• UH Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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