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

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141723
• Other study ID #: F150807003
• Status: Completed
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: August 12, 2017

Study information

• Verified date: June 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: August 12, 2017
• Est. primary completion date: August 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

Inclusion Criteria:

• Estimated gestational age =37 0/7 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 Neonatal Intensive Care Unit admission

• Cesarean section

• Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia Neonatal
• Premature Birth
• Preterm Infant

Intervention

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.
• 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.
• KMC & WHO protocol (1-24 hours)
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive
• 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]

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	University Teaching Hospital, Lusaka, Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate or severe hypothermia at 1 hour after birth (Phase 2A)	Moderate (32.0-35.9C) or severe (<32.0C) hypothermia at 1 hour after birth (via axillary temperature)	1 hour after birth
Primary	Moderate or severe hypothermia at 24 hours or discharge (Phase 2B)	Moderate (32.0-35.9C) or severe (<32.0C) hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)	1 to 24 hours after birth
Secondary	Any hypothermia at 1 hour after birth (Phase 2A)	Any hypothermia (<36.5C) at 1 hour after birth	1 hour after birth
Secondary	Any hypothermia at 1 hour after birth (Phase 2B)	Any hypothermia (<36.5C) at 24 hours or discharge, whichever occurs first	1 to 24 hours or discharge
Secondary	Hyperthermia at 1 hour after birth (Phase 2A)	Hyperthermia (>38.0C) at 1 hour after birth	1 hour after birth
Secondary	Hyperthermia at 1 hour after birth (Phase 2B)	Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first	1 to 24 hours or discharge
Secondary	Skin rash	Skin rash (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Secondary	Neonatal Intensive Care Unit admission	Neonatal Intensive Care Unit admission (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Secondary	Respiratory distress syndrome	Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Secondary	Sepsis	Diagnosis of sepsis (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Secondary	Hypotension, hypoglycemia or seizure	Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Secondary	Death	Death (at 1 hour and before discharge)	1 hour to 24 hours or discharge, or whichever occurs first
Secondary	Maternal body temperature	Maternal body temperature in Celsius	At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first
Secondary	Duration of KMC and plastic bag to infant's body temperature	Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius	During first 1 hour
Secondary	Duration of KMC and plastic bag to infant's body temperature	Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius	During first 24 hours or discharge, or whichever occurs first]