Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission

Sponsor

Hillel Yaffe Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05505903

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.

The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia, Newborn	Diagnostic Test: Temerature measurement

Detailed Description

Introduction Friendly Cesarean section mimics normal vaginal delivery as the newborn is put on mother's chest immediately after delivery and cutting the umbilical cord, and the mother even breastfeeds the newborn infant, if she wishes to. Friendly Cesarean section is offered to the mother if there are no contraindications, such as general anesthesia, fetal distress, or prematurity. Skin to skin contacts lasts for several minutes, as long as the mothers wish to, and depend on mothers' medical state, and newborns' medical state.

In friendly Cesarean section, the skin to skin contact technique includes putting the newborn on mother's chest, and covering them both by a blanket. Yet, during Cesarean section the mother is covered by a thin paper-like sterile sheet, and as the temperature in operating room is low, her skin cools gradually from the spinal anesthesia until actually delivering the newborn infant. So, although the newborn infant is put on the mother's chest and covered by a blanket, there is a possibility for it to develop hypothermia.

Literature about this issue is rare, so the investigators conducted a study to check this possibility.

Methods In Hillel Yaffe medical center nurses measure infants temperature on admission to well-baby nursery (WBN) or neonatal intensive care unit (NICU). Admission is not always performed on arrival, due to other nurse-tasks, such as other newborn infants treatment, or breastfeeding education.

The most measureable piece of data that characterize friendly Cesarean section is the longer time interval from the birth until arrival to WBN or NICU.

Inclusion criteria: infants born within the time study interval. Exclusion criteria: infants born at less than complete 35 gestational weeks, since there is no for offer friendly Cesarean section for these births.

The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Vaginal delivery Newborn Infants born by vaginal delivery.	Diagnostic Test: Temerature measurement Temerature measurement on admission to WBN or NICU
Regular Cesarean section Newborn infants born by regular Cesarean section	Diagnostic Test: Temerature measurement Temerature measurement on admission to WBN or NICU
Friendly Cesarean section Newborn infants born by friendly Cesarean section	Diagnostic Test: Temerature measurement Temerature measurement on admission to WBN or NICU

Arm

Intervention/Treatment

Vaginal delivery

Newborn Infants born by vaginal delivery.

Diagnostic Test: Temerature measurement

Temerature measurement on admission to WBN or NICU

Regular Cesarean section

Newborn infants born by regular Cesarean section

Diagnostic Test: Temerature measurement

Temerature measurement on admission to WBN or NICU

Friendly Cesarean section

Newborn infants born by friendly Cesarean section

Diagnostic Test: Temerature measurement

Temerature measurement on admission to WBN or NICU

Outcome Measures

Primary Outcome Measures

Temperature [1 year]
The temperature upon admission to WBN or NICU

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

all newborn infants

Exclusion Criteria:

infants born after less than 35 complete gestational weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neonatal intensive care unit, Hillel Yaffe medical center	Hadera		Israel	38100

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators

Study Chair: Erez Nadir, MD, Hille Yaffe medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erez Nadir, MD, Principal Investigator, Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT05505903

Other Study ID Numbers:

0032-22-HYMC-IL

First Posted:

Aug 18, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erez Nadir, MD, Principal Investigator, Hillel Yaffe Medical Center

hypothermia

friendly Cesarean section

Additional relevant MeSH terms:

Hypothermia

Study Results

No Results Posted as of Aug 18, 2022