Hypothermia Neonatal, Preterm Infant
Conditions
Keywords
Infant, Newborn, Preterm, Hypothermia, Kangaroo, Plastic, Bag
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.
Interventions
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
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.
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive
In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost \[3 cents per bag\]
Sponsors
University Teaching Hospital, Lusaka, Zambia
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomization at birth followed by randomization at 1 hour
Eligibility
Sex/Gender
ALL
Age
10 Minutes to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate or severe hypothermia at 1 hour after birth (Phase 2A) | 1 hour after birth | Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 1 hour after birth (via axillary temperature) |
| Moderate or severe hypothermia at 24 hours or discharge (Phase 2B) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperthermia at 1 hour after birth (Phase 2A) | 1 hour after birth | Hyperthermia (\>38.0C) at 1 hour after birth |
| Hyperthermia at 1 hour after birth (Phase 2B) | 1 to 24 hours or discharge | Hyperthermia (\>38.0C) at 24 hours or discharge, whichever occurs first |
| Skin rash | 1 hour to 24 hours or discharge, or whichever occurs first | Skin rash (at 1 hour and before discharge) |
| Neonatal Intensive Care Unit admission | 1 hour to 24 hours or discharge, or whichever occurs first | Neonatal Intensive Care Unit admission (at 1 hour and before discharge) |
| Respiratory distress syndrome | 1 hour to 24 hours or discharge, or whichever occurs first | Diagnosis of respiratory distress syndrome (at 1 hour and before discharge) |
| Any hypothermia at 1 hour after birth (Phase 2A) | 1 hour after birth | Any hypothermia (\<36.5C) at 1 hour after birth |
| Hypotension, hypoglycemia or seizure | 1 hour to 24 hours or discharge, or whichever occurs first | Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge) |
| Death | 1 hour to 24 hours or discharge, or whichever occurs first | Death (at 1 hour and before discharge) |
| Maternal body temperature | At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first | Maternal body temperature in Celsius |
| Duration of KMC and plastic bag to infant's body temperature | During first 1 hour | Correlation analysis between duration of KMC +/- plastic bag in minutes to infant's body temperature in Celsius |
| Sepsis | 1 hour to 24 hours or discharge, or whichever occurs first | Diagnosis of sepsis (at 1 hour and before discharge) |
| Any hypothermia at 1 hour after birth (Phase 2B) | 1 to 24 hours or discharge | Any hypothermia (\<36.5C) at 24 hours or discharge, whichever occurs first |
Countries
Zambia
Outcome results
None listed