Efficacy of A Novel in Prevention of Neonatal Hypothermia

NCT05729698 | Completed

• 1 other identifier: Sedacaglar
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypothermia; Newborn; Preterm Birth

Keywords

hypothermia; newborn; body temperature changes; preterm birth

Outcome Measures

Primary Outcomes (4)

• Neonatal hypothermia

  Neonatal hypothermia is defined as temperature \< 36.5C

  immediately after birth

• Neonatal hypothermia

  Neonatal hypothermia is defined as temperature \< 36.5C

  20 minutes after birth

• Neonatal hypothermia

  Neonatal hypothermia is defined as temperature \< 36.5C

  40 minutes after birth

• Neonatal hypothermia

  Neonatal hypothermia is defined as temperature \< 36.5C

  60 minutes after birth

Study Arms (2)

polyethylene bag method

EXPERIMENTAL

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

Other: polyethylene bag

baby warmer swaddle method

EXPERIMENTAL

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

Device: Baby warmer swaddle

Interventions

Baby warmer swaddle DEVICE

Baby Swaddle with Heating System

Also known as: prethermo

baby warmer swaddle method

polyethylene bag OTHER

polyethylene food bag

polyethylene bag method

Eligibility Criteria

• Age: 1 Day - 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, 34381, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypothermia; Premature Birth; Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 15, 2023
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)