Efficacy of A Novel in Prevention of Neonatal Hypothermia

Not Applicable

Completed

• Conditions: Hypothermia; Newborn; Preterm Birth
• Interventions: Other: polyethylene bag; Device: Baby warmer swaddle

• Registration Number: NCT05729698
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-01-16
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Preterms;

• 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

preterms;

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
polyethylene bag method	polyethylene bag	polyethylene bag method: preterm babies will be placed in polythene bags after birth
baby warmer swaddle method	Baby warmer swaddle	baby warmer swaddle group: preterm babies will be placed in baby warmer swaddle after birth

Primary Outcome Measures

Name	Time	Method
Neonatal hypothermia	60 minutes after birth	Neonatal hypothermia is defined as temperature \< 36.5C

Trial Locations

Locations (1)

Istanbul University-Cerrahpaşa; 🇹🇷 Istanbul, Turkey