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Efficacy of A Novel in Prevention of Neonatal Hypothermia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05729698
Enrollment
65
Registered
2023-02-15
Start date
2020-12-01
Completion date
2023-01-01
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Newborn, Preterm Birth

Keywords

hypothermia, newborn, body temperature changes, preterm birth

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.

Interventions

DEVICEBaby warmer swaddle

Baby Swaddle with Heating System

polyethylene food bag

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neonatal hypothermiaimmediately after birthNeonatal hypothermia is defined as temperature \< 36.5C

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026