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

NCT03585192 | Terminated DMC

• 1 other identifier: 09-17-24
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Skin-to-skin interruptions

  The investigators will track the number of times skin-to-skin contact is disrupted within the first hour of life and document reasons for interruption.

  First hour of life

Secondary Outcomes (1)

• Risks for late-preterm neonates

  Length of hospital stay

Study Arms (2)

Skin Group

EXPERIMENTAL

Pulse oximeter probe is placed on right wrist of vigorous neonate after vaginal birth. If randomized to skin group, neonate will initiate skin-to-skin contact after umbilical cord is cut and dried with warm blankets on Mother's abdomen. Length of monitoring will be for first hour of life.

Other: Skin Group

Warmer Group

ACTIVE COMPARATOR

Pulse oximeter probe is placed on right wrist of vigorous neonate after vaginal birth. If randomized to warmer group, neonate will initiate skin-to-skin contact after 20 minutes of observation under the radiant warmer. Length of monitoring will be for first hour of life.

Other: Warmer Group

Interventions

Skin Group OTHER

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.

Skin Group

Warmer Group OTHER

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.

Warmer Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

• Monika Bhola, MD

  UH Cleveland Medical Center MacDonald Women's Hospital

  PRINCIPAL INVESTIGATOR

• Rebecca Walsh, MD

  UH Cleveland Medical Center MacDonald Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatology Fellow, MD

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: November 8, 2017
• Primary Completion: January 31, 2019
• Study Completion: May 1, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)