Efficacy of A Novel in Prevention of Neonatal Hypothermia

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Completed
CT.gov ID
NCT05729698
Collaborator
(none)
65
1
2
25
2.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Baby warmer swaddle
  • Other: polyethylene bag
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy of A Novel in Prevention of Neonatal Hypothermia in Preterm: Baby Warmer Swaddle
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: polyethylene bag method

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

Other: polyethylene bag
polyethylene food bag

Experimental: baby warmer swaddle method

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

Device: Baby warmer swaddle
Baby Swaddle with Heating System
Other Names:
  • prethermo
  • Outcome Measures

    Primary Outcome Measures

    1. Neonatal hypothermia [immediately after birth]

      Neonatal hypothermia is defined as temperature < 36.5C

    2. Neonatal hypothermia [20 minutes after birth]

      Neonatal hypothermia is defined as temperature < 36.5C

    3. Neonatal hypothermia [40 minutes after birth]

      Neonatal hypothermia is defined as temperature < 36.5C

    4. Neonatal hypothermia [60 minutes after birth]

      Neonatal hypothermia is defined as temperature < 36.5C

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 1 Day
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University-Cerrahpaşa Istanbul Turkey 34381

    Sponsors and Collaborators

    • Istanbul University - Cerrahpasa (IUC)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seda Caglar, Assoc. Prof., Istanbul University - Cerrahpasa (IUC)
    ClinicalTrials.gov Identifier:
    NCT05729698
    Other Study ID Numbers:
    • Sedacaglar
    First Posted:
    Feb 15, 2023
    Last Update Posted:
    Feb 15, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seda Caglar, Assoc. Prof., Istanbul University - Cerrahpasa (IUC)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2023