Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Hypothermia, Newborn; Preterm Birth

Treatments: Other: KMC & WHO protocol (1-24 hours); Other: KMC, WHO protocol & bag (1-24 hours); Other: KMC, WHO protocol & bag (0-1 hour); Other: KMC & WHO protocol (0-1 hour)

Study type: Interventional

Funder types: Other

Identifiers

NCT03141736

F150807004

Details and patient eligibility

About

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 preterm infants ≥ 32 to 36 6/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

Full 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 preterm infants ≥ 32 to 36 6/7 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 (this one) and one for infants who are ≥37 weeks gestational age. This preterm 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.

Sex: All

Ages: 10 minutes to 2 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Estimated gestational age ≥32 0/7 - 36 6/7 weeks
• Delivery in the hospital

Exclusion criteria

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder
• Clinically unstable mothers secondary to cardiovascular and pulmonary conditions
• Infants requiring respiratory support beyond 10 minutes after birth
• Infant requiring NICU admission
• C/section
• Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

KMC & WHO protocol (0-1 hour)

Active Comparator group

Description:

The combination of Kangaroo Mother Care (KMC) as continuously as possible together 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.

Treatment:

Other: KMC & WHO protocol (0-1 hour)

KMC & WHO protocol (1-24 hours)

Active Comparator group

Description:

The combination of Kangaroo Mother Care (KMC) as continuously as possible together 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.

Treatment:

Other: KMC & WHO protocol (1-24 hours)

KMC, WHO protocol & bag (0-1 hour)

Experimental group

Description:

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.

Treatment:

Other: KMC, WHO protocol & bag (0-1 hour)

KMC, WHO protocol & bag (1-24 hours

Experimental group

Description:

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.

Treatment:

Other: KMC, WHO protocol & bag (1-24 hours)