Hypothermia, Newborn
Conditions
Keywords
Hypothermia, Hyperthermia, Kangaroo Mother Care, Newborn
Brief summary
The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in term infants (greater than or equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.
Detailed description
The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in term infants (greater than or equal to weeks of gestational age) when compared with routine WHO thermoregulation alone.
Interventions
OTHERContinuous Kangaroo Mother Care to one hour after birth
Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.
OTHERStandard Kangaroo Mother Care to one hour after birth
Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), the infant will receive standard care which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.
Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.
Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), standard treatment will be given which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 2 Weeks
Healthy volunteers
No
Inclusion criteria
* Estimated gestational age greater than or equal to 37 weeks * Delivery in the hospital
Exclusion criteria
* Abdominal wall defect or myelomeningocele * Major congenital anomalies * Blistering skin disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants With Axillary Temperature <36.0 Degrees Celsius | Time of birth to 1 hour | Temperature taken per axilla using digital thermometer |
| Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge | At discharge or 24 hours after birth (whichever is first) | Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number Infants Admitted to the Neonatal Intensive Care Unit | Duration of hospitalization-an average of 2 weeks | Any admission to the neonatal intensive care unit for higher level care |
| Duration of Kangaroo Mother Care | Duration of hospitalization-an average of 2 weeks | Skin to skin contact between baby and mother |
Countries
Zambia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Kangaroo Mother Care to One Hour After Birth Continuous Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-in | 102 |
| Standard Kangaroo Mother Care to One Hour After Birth Standard Kangaroo Mother Care to one hour after birth: Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant bec | 101 |
| Continuous Kangaroo Mother Care to Discharge Continuous Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), the | 81 |
| Standard Kangaroo Mother Care to Discharge Standard Kangaroo Mother Care to discharge: Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (\>38 degrees Celsius), standard treatment will be given which may include remova | 84 |
| Total | 368 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 5 |
Baseline characteristics
| Characteristic | Standard Kangaroo Mother Care to One Hour After Birth | Continuous Kangaroo Mother Care to Discharge | Standard Kangaroo Mother Care to Discharge | Continuous Kangaroo Mother Care to One Hour After Birth | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 101 Participants | 81 Participants | 84 Participants | 102 Participants | 368 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1 hours | 6 hours | 6 hours | 1 hours | 6 hours |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 101 Participants | 81 Participants | 84 Participants | 102 Participants | 368 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Zambia | 101 Participants | 81 Participants | 84 Participants | 102 Participants | 368 Participants |
| Sex: Female, Male Female | 54 Participants | 42 Participants | 46 Participants | 52 Participants | 194 Participants |
| Sex: Female, Male Male | 47 Participants | 39 Participants | 38 Participants | 50 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Infants With Axillary Temperature <36.0 Degrees Celsius
Temperature taken per axilla using digital thermometer
Time frame: Time of birth to 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Kangaroo Mother Care to One Hour After Birth | Number of Infants With Axillary Temperature <36.0 Degrees Celsius | 55 Participants |
| Standard Kangaroo Mother Care to One Hour After Birth | Number of Infants With Axillary Temperature <36.0 Degrees Celsius | 56 Participants |
Primary
Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge
Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth
Time frame: At discharge or 24 hours after birth (whichever is first)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Kangaroo Mother Care to One Hour After Birth | Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge | 14 Participants |
| Standard Kangaroo Mother Care to One Hour After Birth | Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge | 14 Participants |
Secondary
Duration of Kangaroo Mother Care
Skin to skin contact between baby and mother
Time frame: Duration of hospitalization-an average of 2 weeks
Population: Infants in Standard Kanagroo Mother Care to one hour after birth and Standard Kangaroo Mother care to discharge groups received kangaroo mother care only during breastfeeding
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Kangaroo Mother Care to One Hour After Birth | Duration of Kangaroo Mother Care | .6 Hours | Standard Error 0.25 |
| Standard Kangaroo Mother Care to One Hour After Birth | Duration of Kangaroo Mother Care | 0 Hours | Standard Error 0 |
| Continuous Kangaroo Mother Care to Discharge | Duration of Kangaroo Mother Care | 7 Hours | Standard Error 4 |
| Standard Kangaroo Mother Care to Discharge | Duration of Kangaroo Mother Care | 0 Hours | Standard Error 0 |
Secondary
Number Infants Admitted to the Neonatal Intensive Care Unit
Any admission to the neonatal intensive care unit for higher level care
Time frame: Duration of hospitalization-an average of 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Kangaroo Mother Care to One Hour After Birth | Number Infants Admitted to the Neonatal Intensive Care Unit | 0 Participants |
| Standard Kangaroo Mother Care to One Hour After Birth | Number Infants Admitted to the Neonatal Intensive Care Unit | 0 Participants |
| Continuous Kangaroo Mother Care to Discharge | Number Infants Admitted to the Neonatal Intensive Care Unit | 0 Participants |
| Standard Kangaroo Mother Care to Discharge | Number Infants Admitted to the Neonatal Intensive Care Unit | 0 Participants |