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

Study Overview
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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).

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.

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

Conditions
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Neonatal Temperature; Kangaroo Mother Care

Intervention / Treatment
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* Other: Woolen cap


Participation Criteria
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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 Exclusion Criteria: Major congenital malformations Twins Parental refusal to participate to the study

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sepsis defined as Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. |  | Through study completion, an average of 2 weeks. | 
| Number of participants died during hospital stay. |  | 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. |  | From date of randomization until the date discharge,whichever came first, assessed up to 2 weeks. | 
| Age at discharge. |  | From date of birth until the date discharge, whichever came first, assessed up to 2 weeks. |