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Completed

NCT Number: NCT05729698

Efficacy of A Novel in Prevention of Neonatal Hypothermia

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).

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Key information

Age range

1 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpaşa

Istanbul, 34381, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby warmer swaddle

Device

Baby Swaddle with Heating System

Other names: prethermo

polyethylene bag

Other

polyethylene food bag

Primary outcomes

  1. Neonatal hypothermia

    Time frame: immediately after birth

    Neonatal hypothermia is defined as temperature < 36.5C

  2. Neonatal hypothermia

    Time frame: 20 minutes after birth

    Neonatal hypothermia is defined as temperature < 36.5C

  3. Neonatal hypothermia

    Time frame: 40 minutes after birth

    Neonatal hypothermia is defined as temperature < 36.5C

  4. Neonatal hypothermia

    Time frame: 60 minutes after birth

    Neonatal hypothermia is defined as temperature < 36.5C

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 15, 2023
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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