title: Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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 2500 g 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 7 days. 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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov Identifier: NCT02645526 (registered on 31 December 2015).
authors.affiliation: Department of Women and Children Health, University of Padua, Azienda Ospedaliera di Padova, Via Giustiniani, 3, 35128, Padova, Italy. daniele.trevisanuto@gmail.com.
authors.forename: Daniele
authors.initials: D
authors.lastname: Trevisanuto
authors.affiliation: Doctors with Africa CUAMM, Padova, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Putoto
authors.affiliation: Doctors with Africa CUAMM, Central Hospital of Beira, Beira, Mozambique.
authors.forename: Damiano
authors.initials: D
authors.lastname: Pizzol
authors.affiliation: Department of Women and Children Health, University of Padua, Azienda Ospedaliera di Padova, Via Giustiniani, 3, 35128, Padova, Italy.|Doctors with Africa CUAMM, Padova, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Serena
authors.affiliation: Doctors with Africa CUAMM, Padova, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Manenti
authors.affiliation: Department of Pediatrics, University of Bari, Bari, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Varano
authors.affiliation: Doctors with Africa CUAMM, Padova, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Urso
authors.affiliation: Doctors with Africa CUAMM, Oyam District, Uganda.
authors.forename: William
authors.initials: W
authors.lastname: Massavon
authors.affiliation: Doctors with Africa CUAMM, Wolisso, Ethiopia.
authors.forename: Ademe
authors.initials: A
authors.lastname: Tsegaye
authors.affiliation: Department of Pediatrics and Neonatology, Central Hospital of Beira, Beira, Mozambique.
authors.forename: Oliver
authors.initials: O
authors.lastname: Wingi
authors.affiliation: Hospital of Aber, Aber, Uganda.
authors.forename: Emanuel
authors.initials: E
authors.lastname: Onapa
authors.affiliation: Doctors with Africa CUAMM, Padova, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Segafredo
authors.affiliation: , Padova, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cavallin
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D007035:Hypothermia / Q000517:prevention & control*; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D060127:Kangaroo-Mother Care Method; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies
keywords: Cap; Kangaroo mother care; Newborn infant; Temperature