NCT03141723

Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)

Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 2A and 2B)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 10 Minutes – 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Preterm Infant
• Hypothermia Neonatal

Interventions

Type	Name	Description
OTHER	KMC & WHO protocol (0-1 hour)	WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
OTHER	KMC, WHO protocol & bag (0-1 hour)	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.
OTHER	KMC & WHO protocol (1-24 hours)	WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive
OTHER	KMC, WHO protocol & bag (1-24 hours)	In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost \[3 cents per bag\]

Timeline

• Start date: 2017-05-19
• Primary completion: 2017-08-12
• Completion: 2017-08-12
• First posted: 2017-05-05
• Last updated: 2018-06-18

Locations

1 site across 1 country: Zambia