Efficacy of A Novel in Prevention of Neonatal Hypothermia

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729698
• Other study ID #: Sedacaglar
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Newborn
• Premature Birth
• Preterm Birth

Intervention

Device:
• Baby warmer swaddle
Baby Swaddle with Heating System

Other:
• polyethylene bag
polyethylene food bag

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal hypothermia	Neonatal hypothermia is defined as temperature < 36.5C	immediately after birth
Primary	Neonatal hypothermia	Neonatal hypothermia is defined as temperature < 36.5C	20 minutes after birth
Primary	Neonatal hypothermia	Neonatal hypothermia is defined as temperature < 36.5C	40 minutes after birth
Primary	Neonatal hypothermia	Neonatal hypothermia is defined as temperature < 36.5C	60 minutes after birth