Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)
Condition: Preterm Infant; Hypothermia Neonatal
MeSH terms: Premature Birth; Hypothermia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the combination of Kangaroo Mother Care
      (KMC) as continuously as possible together with the use of a plastic bag in combination with
      routine World Health Organization (WHO) thermoregulation care reduces the incidence of
      moderate (32-36° C) or severe (<32.0° C) hypothermia in term infants ≥ 37 0/7 weeks of
      gestational age (GA) when compared to KMC as continuously as possible together with routine
      WHO thermoregulation care.
    

Detailed description: 
      The purpose of this study is to determine whether the combination of Kangaroo Mother Care
      (KMC) as continuously as possible together with the use of a plastic bag in combination with
      routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate
      drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing,
      and appropriate bundling) reduces the incidence of moderate hypothermia (32-36° C) or severe
      (<32.0° C) in term infants ≥ 37 0/7 weeks of gestational age (GA) when compared to KMC as
      continuously as possible together with routine WHO thermoregulation care, as practiced. The
      investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks and one for
      infants who are ≥37 weeks gestational age (this one). This term infant trial will address the
      effectiveness of KMC in combination with plastic bags in decreasing hypothermia in preterm
      infants. The proposed trial will determine whether KMC with plastic bags prevents hypothermia
      in neonates born in a healthcare setting with limited resources where a high risk for
      hypothermia has been reported. Any intervention that decreases morbidity during the neonatal
      period has the potential to impact health beyond the neonatal period,and one that is highly
      cost-effective and easy to use is more likely to be implemented in the developing world.
    

Intervention name(s): KMC & WHO protocol (0-1 hour); KMC, WHO protocol & bag (0-1 hour); KMC & WHO protocol (1-24 hours); KMC, WHO protocol & bag (1-24 hours)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.; In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag] linear low-density bag measuring 10 × 8 × 24 in. and 1.2 mil thick) that will cover the infant's torso and lower extremities.; WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive; In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag]
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization at birth followed by randomization at 1 hour
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infant; Newborn; Preterm; Hypothermia; Kangaroo; Plastic; Bag