Neonatal Temperature; Kangaroo Mother Care Clinical Trial
Official title:
Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?
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).
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.
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