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

NCT03585192 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-05-03

No results posted yet for this study

Summary

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.

Conditions

  • Safety Issues

Interventions

OTHER

Skin Group

1. If the newborn is vigorous (crying, good respiratory effort, good tone) after vaginal delivery, newborn will be able to go directly to Mother's chest for immediate SSC 2. A pulse oximeter will be placed on the newborn's right wrist. Saturations will be monitored on a pulse oximeter located next to the Mother's bed for the first hour of life.

OTHER

Warmer Group

1. Newborn will go to the radiant warmer, pulse oximeter placed on newborn's right wrist, and saturations will be monitored on the Panda Warmer. 2. If stable per Baby RN after 20 minutes of observation, the newborn will be placed on Mother's chest for SSC. Vital signs will be monitored for the first hour of life.

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Monika Bhola, MD · UH Cleveland Medical Center MacDonald Women's Hospital

  • Rebecca Walsh, MD · UH Cleveland Medical Center MacDonald Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2019-01-31
Completion
2019-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585192 on ClinicalTrials.gov