Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial

Daniele Trevisanuto, Giovanni Putoto, Damiano Pizzol, Tiziana Serena, Fabio Manenti, Silvia Varano, Eleonora Urso, William Massavon, Ademe Tsegaye, Oliver Wingi, Emanuel Onapa, Giulia Segafredo, Francesco Cavallin

Research output: Contribution to journalArticlepeer-review


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 on temperature control during KMC remains to be established. In the hospitals participating in the projects of the non-governmental organization CUAMM, KMC represents a standard of care, but the heads of the babies often remain uncovered due to local habits or to the unavailability of a cap. The aim of the present study will be to assess the effectiveness and safety of using a woolen cap in maintaining normothermia in low-birth-weight infants (LBWI) during KMC. Methods/design: This is a multicenter (three hospitals), multicountry (three countries), prospective, unblinded, randomized controlled trial of KMC treatment with and without a woolen cap in LBWI. After obtaining parental consent, all infants with a birth weight below 2500g and who are candidates for KMC, based on the clinical decision of the attending physician, will be assigned to the KMC with a woolen cap group or to the KMC without a woolen cap group in a 1:1 ratio according to a computer-generated, randomized sequence. The duration of the study will be until the patient's discharge, with a maximum treatment duration of 7days. The primary outcome measure will be whether the infants' temperatures remain within the normal range (36.5-37.5°C) in the course of KMC during the intervention. In all participants, axillary temperature will be measured with a digital thermometer four 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; and age at discharge. Discussion: The findings of this study will be important for other units/settings in high- as well low-resource countries where KMC is routinely performed. Based on the results of the present study, we could speculate whether the use of a woolen cap may help to maintain the neonate within the normal thermal range. Furthermore, potential complications such as hyperthermia will be strictly monitored and collected. Trial registration: Identifier: NCT02645526(registered on 31 December 2015).

Original languageEnglish
Article number265
Issue number1
Publication statusPublished - May 26 2016


  • Cap
  • Kangaroo mother care
  • Newborn infant
  • Temperature

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)


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