None listed
Conditions
Brief summary
The aim of this trial is to determine whether the thermal jacket is effective to attain and maintain euthermia (36.5°C to 37.5°C) for hypothermic (35.0°C to 36.4°C) preterm or low birthweight neonates in clinical settings in Bangladesh. For this we will equip a multi-block crossover randomized control trial design, in which every enrolled neonate will get the experimental treatment (thermal jacket) and comparator treatment (kangaroo mother care). Each event will either consist of thermal jacket or kangaroo mother care, where an event is a follow up period of 2 hours. The body temperature will then be compared to assess the efficacy of thermal jacket as a supplement to kangaroo mother care.
Interventions
The intervention, Thermal Jacket, is a thermal care device consisting of a chemical warming pad (CWP) and an insulating jacket. The intervention can be administered by mothers or primary caregivers and, since this is a supplement to Kangaroo Mother Care (KMC), mothers or primary caregivers can use this whenever providing KMC is not possible. The intervention can maintain a temperature between 36.5°C and 37.5°C for 2 hours. Moreover, the device contains a transparent window above the neonate's ch
The intervention, Thermal Jacket, is a thermal care device consisting of a chemical warming pad (CWP) and an insulating jacket. The intervention can be administered by mothers or primary caregivers and, since this is a supplement to Kangaroo Mother Care (KMC), mothers or primary caregivers can use this whenever providing KMC is not possible. The intervention can maintain a temperature between 36.5°C and 37.5°C for 2 hours. Moreover, the device contains a transparent window above the neonate's chest, which helps observe the neonate’s breathing frequency. During a day, thermal jacket doesn’t have any time limits of use. Once a neonate is wrapped by the thermal jacket, he/she should stay in the jacket for 2 hours (maximum) at a time. Moreover, the World Health Organization (WHO) and Bangladesh National Guideline on Kangaroo Mother Care suggest the use of KMC for 8-24 hours per day, until neonates gain a weight of 2500 gm. As a supplement to KMC, thermal jacket is suggested to use as supplement to KMC until the neonate reaches the weight of 2500 gm
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
0 to 72 Hours
Healthy volunteers
No
Inclusion criteria
Neonate aged between 0-72 hours Heart rate 100-160 per minute Capillary Refill Time <= 3 sec Respiratory rate 30-59 per minute Breaths comfortable Pink in the room air
Exclusion criteria
In nasogastric tube In oxygen therapy In intravenous fluid Sign of respiratory distress Prolonged or frequent apnea Major surgical problem Gross congenital anomaly
Outcome results
None listed