Thermal Effect of a Woolen Cap in
Low Birthweight Infants during Kangaroo Care

Randomization
Eligible infants were assigned to CAP or NOCAP arms in a 1:1 ratio according to a computer-generated, randomized sequence for each participating hospital. Detailed information are available in the study protocol.[23] Contamination between arms was not allowed.
Procedure
The procedure of initiating, maintaining and stopping the KMC was based on WHO guidelines [18]. In both groups, mothers were asked to clothe the baby with a pre-warmed shirt open at the front, a napkin and socks; however, the use of additional garments was not strictly controlled and was left to maternal decision. All mothers were trained in monitoring the baby’s condition and in recognizing dangerous clinical signs during KMC. Newborns randomly allocated to the intervention arm were provided with a woolen cap in addition to standard WHO thermoregulatory practices during KMC.[23] Newborns randomized in the control arm received standard WHO thermoregulatory practices during KMC. All the caps used for the study were handmade by a group of volunteers in Padua and were standardized by the head size (small or large) (FIGURE 1). The material (heavy wool) was provided by Doctors with Africa CUAMM.[24] Caps were changed and washed if they were dirty or wet. Study duration was until patient discharge, death, or 7 days maximum. In case of documented neonatal hypothermia (temperature below 36.5 °C) or hyperthermia (temperature above 37.5 °C) during the course of the study, a pre-warmed blanket was added or removed. In case of maternal hyperthermia, the woman was asked to wear lighter clothes. In these cases, neonatal and maternal temperatures were then measured every hour until the normal range was reached. When data collector approached the mother to measure temperatures and she was not in KMC, she was asked to place her infant in SSC, but temperature was still registered before the change.

Outcomes
The primary outcome was the time spent in the normal thermal range (36.5-37.5 °C) during KMC. In addition, the time spent in temperature below normal range (<36.5°C) and the time spent in temperature above normal range (>37.5°C) were also evaluated.[15] In each patient, the time spent with temperature in a predefined range was evaluated as the number of readings with temperature in that range on the total available readings. Secondary outcomes were: i) respiratory problems including tachypnea (respiratory rate > 60 breaths/min) and/or dyspnea and/or apnea; ii) sepsis, defined as the presence of at least two of the following clinical signs: lethargy, persistent apnea, poor feeding or fever; iii) mortality before hospital discharge; iv) in-hospital growth, defined as weight increment from birth to discharge. Information on the number of episodes of apnea (as stated in the study protocol) [23] could not be collected due to organizational problems, thus the occurrence of respiratory problems was evaluated instead.
Data collection
In all participants, axillary temperature was measured with a digital thermometer (C202; Terumo, Tokyo, Japan) every 6 hours (6.00 am, 12.00 am, 6.00 pm, and 12.00 pm). Maternal temperature, room temperature and adherence to SSC were registered at the same time-points. Room temperature was measured by using the same wall thermometers (Oregon Scientific RMR262) in all three study sites. Neonatal and maternal characteristics were collected at birth and at admission to KMC room. Respiratory problems, sepsis, weight at discharge and death were collected during hospital stay. Additional information on expected serious adverse events (SAEs) was also collected. Data collection was performed by an observer who was not involved in the care of the neonates. All data were anonymized.
Safety
SAE were defined as unexpected death, apnea not responding to vigorous stimulation,

Rivista Italiana on line "LA CARE" Volume 11, Numero 1-2, anno 2018