Clinical trial NCT05729698: Efficacy of A Novel in Prevention of Neonatal Hypothermia
Official title: Efficacy of A Novel in Prevention of Neonatal Hypothermia in Preterm: Baby Warmer Swaddle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Newborn
Preterm Birth
Keywords: hypothermia
newborn
body temperature changes
preterm birth
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal hypothermia
timeFrame: immediately after birth
measure: Neonatal hypothermia
timeFrame: 20 minutes after birth
measure: Neonatal hypothermia
timeFrame: 40 minutes after birth
measure: Neonatal hypothermia
timeFrame: 60 minutes after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
References: