An interventional study of KMC & WHO protocol (0-1 hour) and KMC, WHO protocol & bag (0-1 hour) in Preterm Birth and Hypothermia, Newborn, sponsored by University of Alabama at Birmingham. Withdrawn. Open to participants aged 10 Minutes to 2 Hours. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
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Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
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.
Other: 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.
Other: KMC & WHO protocol (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.
Other: 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.
Other: KMC, WHO protocol & bag (1-24 hours)
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 non-medical low-cost \[3 cents per bag\]
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 non-medical low-cost \[3 cents per bag\]
Moderate or severe hypothermia at 1 hour after birth (Phase 1A)
Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 1 hour after birth (via axillary temperature)
Time frame: 1 hour after birth
Moderate or severe hypothermia at 24 hours or discharge (Phase 1B)
Moderate (32.0-35.9C) or severe (\<32.0C) hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)
Time frame: 1 to 24 hours after birth
Any hypothermia at 1 hour after birth (Phase 1A)
Any hypothermia (\<36.5C) at 1 hour after birth
Time frame: 1 hour after birth
Any hypothermia at 24 hours or discharge (Phase 1B)
Any hypothermia (\<36.5C) at 24 hours or discharge, whichever occurs first
Time frame: 1 to 24 hours or discharge
Hyperthermia at 1 hour after birth (Phase 1A)
Hyperthermia (\>38.0C) at 1 hour after birth
Time frame: 1 hour after birth
Hyperthermia at 24 hours or discharge (Phase 1B)
Hyperthermia (\>38.0C) at 24 hours or discharge, whichever occurs first
Time frame: 1 to 24 hours or discharge
Skin rash
Skin rash (at 1hour and before discharge)
Time frame: 1hour to 24 hours or discharge, or whichever occurs first
Neonatal Intensive Care Unit admission
Neonatal Intensive Care Unit admission (at 1 hour and before discharge)
Time frame: 1hour to 24 hours or discharge, or whichever occurs first
Respiratory distress syndrome
Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)
Time frame: 1hour to 24 hours or discharge, or whichever occurs first
Sepsis
Diagnosis of sepsis (at 1hour and before discharge)
Time frame: 1hour to 24 hours or discharge, or whichever occurs first
Hypotension, hypoglycemia or seizure
Diagnosis of any of the following; hypotension, hypoglycemia or seizure (at 1hour and before discharge)
Time frame: 1hour to 24 hours or discharge, or whichever occurs first
Death
Death (at 1hour and before discharge)
Time frame: 1hour to 24 hours or discharge, or whichever occurs first
Maternal body temperature
Maternal body temperature in Celsius
Time frame: At birth, at 1 hour, every four hours until 24 hours or discharge, whichever occurs first
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
Time frame: During first 1 hour
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
Time frame: During first 24 hours or discharge, or whichever occurs first
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham