Efficacy of A Novel in Prevention of Neonatal Hypothermia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypothermia, Newborn, Preterm Birth

Intervention / Treatment
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* Device: Baby warmer swaddle
* Other: polyethylene bag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermia, newborn, body temperature changes, preterm birth