NCT05505903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,412

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

October 4, 2021

Last Update Submit

March 10, 2023

Conditions

Hypothermia, Newborn

Keywords

hypothermiafriendly Cesarean section

Outcome Measures

Primary Outcomes (1)

  • Temperature

    The temperature upon admission to WBN or NICU

    1 year

Study Arms (3)

Vaginal delivery

Newborn Infants born by vaginal delivery.

Diagnostic Test: Temerature measurement

Regular Cesarean section

Newborn infants born by regular Cesarean section

Diagnostic Test: Temerature measurement

Friendly Cesarean section

Newborn infants born by friendly Cesarean section

Diagnostic Test: Temerature measurement

Interventions

Temerature measurementDIAGNOSTIC_TEST

Temerature measurement on admission to WBN or NICU

Friendly Cesarean sectionRegular Cesarean sectionVaginal delivery

Eligibility Criteria

AgeUp to 2 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants born at Hillel Yaffe meducal center

You may qualify if:

  • all newborn infants

You may not qualify if:

  • infants born after less than 35 complete gestational weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal intensive care unit, Hillel Yaffe medical center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erez Nadir, MD

    Hille Yaffe medical center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2021

First Posted

August 18, 2022

Study Start

March 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)