Skip to main content
Clinical Trials/NCT05729698
NCT05729698
Completed
Not Applicable

Efficacy of A Novel in Prevention of Neonatal Hypothermia in Preterm: Baby Warmer Swaddle

Istanbul University - Cerrahpasa (IUC)1 site in 1 country65 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypothermia
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
65
Locations
1
Primary Endpoint
Neonatal hypothermia
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia.

Design: Randomized controlled clinical trial Setting: The research was carried out in the NICU of a training and research hospital in Istanbul.

Method: A total of 65 babies between 32-37 weeks of gestation were included in the study. In accordance with the routine procedure of the clinic, preterm babies wrapped in polyethylene bags after birth formed the control group (n=33), while babies wrapped in polyethylene bags and placed in a swaddle with a heating system formed the experimental group (n=32).

Detailed Description

Although neonatal hypothermia has higher rates especially in underdeveloped and developing countries, it is a global health problem also seen in developed countries. In a meta-analysis study, the prevalence of neonatal hypothermia was reported as 57.2% in East Africa. In a multicenter, prospective study, 79.6% of preterm newborns were admitted to NICUs with hypothermia in Ethiopia. In a study, the incidence of hypothermia to be 53% in the first 24 hours of life in preterm infants they conducted in a hospital in France. In a study, in 28 countries with upper-middle income status, admission temperature data of a total of 454,617 very low birth weight infants from 2009 to 2016 were analyzed. Although these data showed an improvement in hypothermia rates ranging from 52.6% (2009) to 38.2% (2016), approximately 4 out of 10 infants experienced hypothermia when admitted to the NICU. Similarly, in the United Kingdom, the National Neonatal Monitoring Program reported the prevalence of hypothermia as 28% and 25% for babies born in 2015 and 2016, respectively, emphasizing hypothermia as an ongoing problem.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
January 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Seda Caglar

Assoc. Prof.

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • between 32-37 GH,
  • with an indication for hospitalization in the NICU,
  • with a body temperature of 36.4 °C and above in the axillary route immediately after birth,
  • with a maternal body temperature between 36.4 °C and 38 °C in the tympanic route are included in the study

Exclusion Criteria

  • with congenital anomalies,
  • who were transported to another hospital, or who were transported to the hospital where the research was conducted from an external center

Outcomes

Primary Outcomes

Neonatal hypothermia

Time Frame: 60 minutes after birth

Neonatal hypothermia is defined as temperature \< 36.5C

Study Sites (1)

Loading locations...

Similar Trials