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Efficacy of A Novel in Prevention of Neonatal Hypothermia

Primary Purpose

Hypothermia, Newborn, Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Baby warmer swaddle
polyethylene bag
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia focused on measuring hypothermia, newborn, body temperature changes, preterm birth

Eligibility Criteria

1 Day - 1 Day (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

polyethylene bag method

baby warmer swaddle method

Arm Description

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

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

Outcomes

Primary Outcome Measures

Neonatal hypothermia
Neonatal hypothermia is defined as temperature < 36.5C
Neonatal hypothermia
Neonatal hypothermia is defined as temperature < 36.5C
Neonatal hypothermia
Neonatal hypothermia is defined as temperature < 36.5C
Neonatal hypothermia
Neonatal hypothermia is defined as temperature < 36.5C

Secondary Outcome Measures

Full Information

First Posted
January 16, 2023
Last Updated
February 6, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05729698
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Newborn, Preterm Birth
Keywords
hypothermia, newborn, body temperature changes, preterm birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polyethylene bag method
Arm Type
Experimental
Arm Description
polyethylene bag method: preterm babies will be placed in polythene bags after birth
Arm Title
baby warmer swaddle method
Arm Type
Experimental
Arm Description
baby warmer swaddle group: preterm babies will be placed in baby warmer swaddle after birth
Intervention Type
Device
Intervention Name(s)
Baby warmer swaddle
Other Intervention Name(s)
prethermo
Intervention Description
Baby Swaddle with Heating System
Intervention Type
Other
Intervention Name(s)
polyethylene bag
Intervention Description
polyethylene food bag
Primary Outcome Measure Information:
Title
Neonatal hypothermia
Description
Neonatal hypothermia is defined as temperature < 36.5C
Time Frame
immediately after birth
Title
Neonatal hypothermia
Description
Neonatal hypothermia is defined as temperature < 36.5C
Time Frame
20 minutes after birth
Title
Neonatal hypothermia
Description
Neonatal hypothermia is defined as temperature < 36.5C
Time Frame
40 minutes after birth
Title
Neonatal hypothermia
Description
Neonatal hypothermia is defined as temperature < 36.5C
Time Frame
60 minutes after birth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
Istanbul
ZIP/Postal Code
34381
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of A Novel in Prevention of Neonatal Hypothermia

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