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)
NCT number | NCT03141723 |
Other study ID # | F150807003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 19, 2017 |
Est. completion date | August 12, 2017 |
Verified date | June 2018 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Zambia | University Teaching Hospital | Lusaka |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | University Teaching Hospital, Lusaka, Zambia |
Zambia,
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] |
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