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

Not Applicable

Withdrawn

• Conditions: Preterm Birth; Hypothermia, Newborn
• Interventions: Other: KMC, WHO protocol & bag (0-1 hour); Other: KMC & WHO protocol (1-24 hours); Other: KMC, WHO protocol & bag (1-24 hours); Other: KMC & WHO protocol (0-1 hour)

• Registration Number: NCT03141736
• Lead Sponsor: University of Alabama at Birmingham

Brief 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 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.

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 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.

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07
• Study Start: 2024-11-19
• Primary Completion: 2025-10-12
• Study Completion: 2025-10-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KMC, WHO protocol & bag (0-1 hour)	KMC, WHO protocol & bag (0-1 hour)	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.
KMC & WHO protocol (1-24 hours)	KMC & WHO protocol (1-24 hours)	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.
KMC, WHO protocol & bag (1-24 hours	KMC, WHO protocol & bag (1-24 hours)	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.
KMC & WHO protocol (0-1 hour)	KMC & WHO protocol (0-1 hour)	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.

Primary Outcome Measures

Name	Time	Method
Moderate or severe hypothermia at 24 hours or discharge (Phase 1B)	1 to 24 hours after birth	Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)
Moderate or severe hypothermia at 1 hour after birth (Phase 1A)	1 hour after birth	Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 1 hour after birth (via axillary temperature)

Secondary Outcome Measures

Name	Time	Method
Any hypothermia at 1 hour after birth (Phase 1A)	1 hour after birth	Any hypothermia (\<36.5C) at 1 hour after birth
Sepsis	1hour to 24 hours or discharge, or whichever occurs first	Diagnosis of sepsis (at 1hour and before discharge)
Any hypothermia at 24 hours or discharge (Phase 1B)	1 to 24 hours or discharge	Any hypothermia (\<36.5C) at 24 hours or discharge, whichever occurs first
Hyperthermia at 1 hour after birth (Phase 1A)	1 hour after birth	Hyperthermia (\>38.0C) at 1 hour after birth
Hyperthermia at 24 hours or discharge (Phase 1B)	1 to 24 hours or discharge	Hyperthermia (\>38.0C) at 24 hours or discharge, whichever occurs first
Skin rash	1hour to 24 hours or discharge, or whichever occurs first	Skin rash (at 1hour and before discharge)
Maternal body temperature	At birth, at 1 hour, every four hours until 24 hours or discharge, whichever occurs first	Maternal body temperature in Celsius
Death	1hour to 24 hours or discharge, or whichever occurs first	Death (at 1hour and before discharge)
Duration of KMC and plastic bag to infant's body temperature	During first 24 hours or discharge, or whichever occurs first	Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius
Hypotension, hypoglycemia or seizure	1hour to 24 hours or discharge, or whichever occurs first	Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge)
Neonatal Intensive Care Unit admission	1hour to 24 hours or discharge, or whichever occurs first	Neonatal Intensive Care Unit admission (at 1 hour and before discharge)
Respiratory distress syndrome	1hour to 24 hours or discharge, or whichever occurs first	Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia