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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Neonatal Temperature; Kangaroo Mother Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KMC with woolen cap

In this group, the head of the patients will be covered with a woolen cap during KMC.

Group Type EXPERIMENTAL

Woolen cap

Intervention Type OTHER

KMC without woolen cap

In this group, the head of the patients will be uncovered during KMC.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Woolen cap

Intervention Type OTHER

Eligibility Criteria

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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