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

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia, Newborn
• Intervention / Treatment: 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.

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.

• Study Type: Observational
• Enrollment (Actual): 2412

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Neonatal intensive care unit, Hillel Yaffe medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 hours (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants born at Hillel Yaffe meducal center

Description

Inclusion Criteria:

• all newborn infants

Exclusion Criteria:

• infants born after less than 35 complete gestational weeks

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature	The temperature upon admission to WBN or NICU	1 year

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: hypothermia; friendly Cesarean section
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: 0032-22-HYMC-IL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No