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
|Condition or disease||Intervention/treatment||Phase|
|Safety Issues||Other: Skin Group Other: Warmer Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|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|
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
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
- 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.
- 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.
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
|United States, Ohio|
|UH Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|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|