Efficacy of A Novel in Prevention of Neonatal Hypothermia

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

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).

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Hypothermia; Newborn
• Intervention / Treatment: Other: polyethylene bag; Device: Baby warmer swaddle

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34381
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 day (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: polyethylene bag method; polyethylene bag method: preterm babies will be placed in polythene bags after birth	Other: polyethylene bag; polyethylene food bag
Experimental: baby warmer swaddle method; baby warmer swaddle group: preterm babies will be placed in baby warmer swaddle after birth	Device: Baby warmer swaddle; Baby Swaddle with Heating System; Other Names: prethermo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal hypothermia	Neonatal hypothermia is defined as temperature < 36.5C	immediately after birth
Neonatal hypothermia	Neonatal hypothermia is defined as temperature < 36.5C	20 minutes after birth
Neonatal hypothermia	Neonatal hypothermia is defined as temperature < 36.5C	40 minutes after birth
Neonatal hypothermia	Neonatal hypothermia is defined as temperature < 36.5C	60 minutes after birth

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: preterm birth; newborn; hypothermia; body temperature changes
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Body Temperature Changes; Premature Birth; Hypothermia
• Other Study ID Numbers: Sedacaglar

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