Efficacy of A Novel in Prevention of Neonatal Hypothermia

NCT ID: NCT05729698

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2023-01-01

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.

Conditions

Hypothermia; Newborn; Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

polyethylene bag method

polyethylene bag method: preterm babies will be placed in polythene bags after birth

Group Type: EXPERIMENTAL

polyethylene bag

Intervention Type: OTHER

polyethylene food bag

baby warmer swaddle method

baby warmer swaddle group: preterm babies will be placed in baby warmer swaddle after birth

Group Type: EXPERIMENTAL

Baby warmer swaddle

Intervention Type: DEVICE

Baby Swaddle with Heating System

Interventions

Baby warmer swaddle

Baby Swaddle with Heating System

Intervention Type: DEVICE

polyethylene bag

polyethylene food bag

Intervention Type: OTHER

Other Intervention Names

prethermo

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Seda Caglar

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University-Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Sedacaglar

Identifier Type: -

Identifier Source: org_study_id