Clinical trial NCT03141723: Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)
Official title: Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 2A and 2B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Hypothermia Neonatal
Keywords: Infant
Newborn
Preterm
Hypothermia
Kangaroo
Plastic
Bag
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University Teaching Hospital, Lusaka, Zambia
First posted: 2017-05-05
Enrollment: 423
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization at birth followed by randomization at 1 hour
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Moderate or severe hypothermia at 1 hour after birth (Phase 2A)
timeFrame: 1 hour after birth
measure: Moderate or severe hypothermia at 24 hours or discharge (Phase 2B)
timeFrame: 1 to 24 hours after birth
Secondary outcomes:
measure: Any hypothermia at 1 hour after birth (Phase 2A)
timeFrame: 1 hour after birth
measure: Any hypothermia at 1 hour after birth (Phase 2B)
timeFrame: 1 to 24 hours or discharge
measure: Hyperthermia at 1 hour after birth (Phase 2A)
timeFrame: 1 hour after birth
measure: Hyperthermia at 1 hour after birth (Phase 2B)
timeFrame: 1 to 24 hours or discharge
measure: Skin rash
timeFrame: 1 hour to 24 hours or discharge, or whichever occurs first
measure: Neonatal Intensive Care Unit admission
timeFrame: 1 hour to 24 hours or discharge, or whichever occurs first
measure: Respiratory distress syndrome
timeFrame: 1 hour to 24 hours or discharge, or whichever occurs first
measure: Sepsis
timeFrame: 1 hour to 24 hours or discharge, or whichever occurs first
measure: Hypotension, hypoglycemia or seizure
timeFrame: 1 hour to 24 hours or discharge, or whichever occurs first
measure: Death
timeFrame: 1 hour to 24 hours or discharge, or whichever occurs first
measure: Maternal body temperature
timeFrame: At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first
measure: Duration of KMC and plastic bag to infant's body temperature
timeFrame: During first 1 hour
measure: Duration of KMC and plastic bag to infant's body temperature
timeFrame: During first 24 hours or discharge, or whichever occurs first]
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P Travers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
References:
citation: Travers CP, Ramani M, Gentle SJ, Schuyler A, Brown C, Dills MM, Davis CB, Mwenechanya M, Chomba E, Aban I, Manasyan A, Ambalavanan N, Carlo WA. Early Skin-to-Skin Care with a Polyethylene Bag for Neonatal Hypothermia: A Randomized Clinical Trial. J Pediatr. 2021 Apr;231:55-60.e1. doi: 10.1016/j.jpeds.2020.12.064. Epub 2020 Dec 26.