Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?

January 17, 2017 updated by: Daniele Trevisanuto, University Hospital Padova
The aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care (KMC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Neonatal hypothermia is an important challenge associated with morbidity and mortality. Preventing neonatal hypothermia is important in high resource countries, but is of fundamental importance in low resource settings where supportive care is limited.

Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. During KMC, the World Health Organization (WHO) guidelines recommend the use of a cap/hat, but its effect temperature control during KMC remains to be established.

In the hospitals participating to the projects of the non-governmental organization CUAMM, KMC represents a standard of care, but the head of the babies often remains uncovered due to local habits or to the unavailability of a cap.

Objective: The aim of the present study will be to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during KMC.

Methods: This is a multicenter (three hospitals), multi country (three countries), prospective, unblinded, randomized clinical trial of KMC treatment with and without a woolen cap in LBWI. After obtaining parental consent, all infants with a birth weight <2500 g and candidate to KMC will be assigned to KMC with woolen cap or to KMC without cap group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome measure will be the temperature in the normal range (36.5-37.5°C) in course of KMC during the first week of life. In all participants, axillary temperature will be measured with a digital thermometer 4 times per day. In addition, maternal and room temperature will be recorded. Secondary outcome measures will be: episodes of apnea; sepsis; mortality before hospital discharge; in-hospital growth; age at discharge.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • IT-Italy
      • Padua, IT-Italy, Italy, 35128
        • Daniele Trevisanuto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Birth weight <2500 g (and)
  • Candidate to KMC treatment (and)
  • Parental consent; a written informed consent will be obtained by a member of the neonatal - Team involved in the study from a parent or guardian before KMC treatment

Exclusion Criteria:

  • Major congenital malformations
  • Twins
  • Parental refusal to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KMC with woolen cap
In this group, the head of the patients will be covered with a woolen cap during KMC.
Other: Woolen cap
No Intervention: KMC without woolen cap
In this group, the head of the patients will be uncovered during KMC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal temperature in the normal range (36.5-37.5°C) in course of KMC treatment.
Time Frame: First week of life.
First week of life.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Sepsis defined as Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Time Frame: Through study completion, an average of 2 weeks.
Through study completion, an average of 2 weeks.
Number of participants died during hospital stay.
Time Frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 weeks.
From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 weeks.
Rate of growth (g/kg/die) during hospital stay.
Time Frame: From date of randomization until the date discharge,whichever came first, assessed up to 2 weeks.
From date of randomization until the date discharge,whichever came first, assessed up to 2 weeks.
Age at discharge.
Time Frame: From date of birth until the date discharge, whichever came first, assessed up to 2 weeks.
From date of birth until the date discharge, whichever came first, assessed up to 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Padova

Collaborators

Doctors with Africa - Collegio Universitario Aspiranti Medici Missionari (CUAMM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CUAMMcap

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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