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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585192
Recruitment Status : Terminated (Enrollment closed due to impending graduation from Fellowship)
First Posted : July 12, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rebecca Walsh, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Safety Issues Other: Skin Group Other: Warmer Group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates - A Pilot Study
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : May 1, 2019

Arm Intervention/treatment
Experimental: Skin Group
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
  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.

Active Comparator: Warmer Group
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
  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.




Primary Outcome Measures :
  1. Skin-to-skin interruptions [ Time Frame: First hour of life ]
    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.


Secondary Outcome Measures :
  1. Risks for late-preterm neonates [ Time Frame: Length of hospital stay ]
    The investigators will track the baby's temperature to monitor for hypothermia, glucose levels to monitor for hypoglycemia, and if there is transfer to the Neonatal Intensive Care Unit (NICU) anytime during hospital stay.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT03585192


Locations
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United States, Ohio
UH Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Monika Bhola, MD UH Cleveland Medical Center MacDonald Women's Hospital
Principal Investigator: Rebecca Walsh, MD UH Cleveland Medical Center MacDonald Women's Hospital
  Study Documents (Full-Text)

Documents provided by Rebecca Walsh, University Hospitals Cleveland Medical Center:
Study Protocol  [PDF] October 24, 2017


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Responsible Party: Rebecca Walsh, Neonatology Fellow, MD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03585192     History of Changes
Other Study ID Numbers: 09-17-24
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No