Hypothermia, NewbornNCT02189746
Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants
A study testing Continuous Kangaroo Mother Care to 1 hour after birth, Standard Kangaroo Mother Care to 1 hour after birth and Continuous Kangaroo Mother Care to discharge in people with Hypothermia, Newborn, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial 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 preterm infants (32-36 6/7 weeks of gestational age) when compared with… Read more about this study
- Who is it for?
- Ages 1 minute to 8 weeks
- Conditions the study is for
- Hypothermia, Newborn
- What is being tested?
- Continuous Kangaroo Mother Care to 1 hour after birth, Standard Kangaroo Mother Care to 1 hour after birth and Continuous Kangaroo Mother Care to discharge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteZambia
- Study dates
- Jun 2014to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated gestational age 32-36 6/7 weeks
- Delivery in the hospital
Who cannot join
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B
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 preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.
Read the 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 preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.
- Conditions
- Hypothermia, Newborn
- Being tested
- Continuous Kangaroo Mother Care to 1 hour after birth, Standard Kangaroo Mother Care to 1 hour after birth, Continuous Kangaroo Mother Care to discharge, Standard Kangaroo Mother Care to discharge
- Keywords
- Hypothermia, Newborn, Hyperthermia, Kangaroo mother care
- Medical subject headings
- Hypothermia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Kangaroo Mother Care to 1 hour after birthOther
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.
Standard Kangaroo Mother Care to 1 hour after birthOther
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.
Continuous Kangaroo Mother Care to dischargeOther
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.
Standard Kangaroo Mother Care to dischargeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Kangaroo Mother Care to 1 hour after birth | Active comparator | In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth. Receives: Other: Continuous Kangaroo Mother Care to 1 hour after birth |
| Standard Kangaroo Mother Care to 1 hour after birth | Sham comparator | Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth. Receives: Other: Standard Kangaroo Mother Care to 1 hour after birth |
| Continuous Kangaroo Mother Care to discharge | Active comparator | In addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge. Receives: Other: Continuous Kangaroo Mother Care to discharge |
| Standard Kangaroo Mother Care to discharge | Sham comparator | Infants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge. Receives: Other: Standard Kangaroo Mother Care to discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Measured: Time of birth to 1 hour
Axillary Temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Measured: At discharge or 24 hours after birth (whichever is first)
Secondary outcomes (9)
Blood pressure
Measure of extremity blood pressure per cuff taken during nursery stay.
Measured: Duration of hospitalization-expected average of 4 weeks
Blood glucose
Measure of blood glucose per laboratory value taken per heelstick
Measured: Duration of hospitalization-expected average of 4 weeks
Seizure
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Measured: Duration of hospitalization-expected average of 4 weeks
Respiratory Distress Syndrome (RDS)
Documentation of increased work of breathing, retractions, and need for oxygen, intubation or surfactant
Measured: Duration of hospitalization-expected average of 4 weeks
Sepsis
Culture proven or culture negative clinically treated course consistent with sepsis
Measured: Duration of hospitalization-expected average of 4 weeks
Neonatal Intensive Care Unit Admission
Any admission to NICU for need for higher level care
Measured: Duration of hospitalization-expected average of 4 weeks
Death
Cardiorespiratory failure
Measured: Duration of hospitalization-expected average of 4 weeks
Any Axillary Temperature < 36.0 degrees Celsius
Temperature taken per axilla for one minute
Measured: Duration of hospitalization-expected average of 4 weeks
Duration of Kangaroo Mother Care
Skin to skin contact between infant and mother
Measured: Duration of hospitalization-expected average 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, NewbornStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manimaran Ramani, MD, University of Alabama at Birmingham
- Investigators
- Waldemar A Carlo, MD, Study director, University of Alabama at BirminghamManimaran Ramani, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189746
- Sponsor's protocol ID
- UAB Neo 011
- Status last verified
- Jan 2018
- First submitted
- 11 Jul 2014
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Kangaroo Mother Care to Prevent Neonatal Hypothermia - Trials 1A & 1B
- ClinicalTrials.gov ID
- NCT02189746
- Acronym / sponsor ID
- UAB Neo 011
- Conditions
- Hypothermia, Newborn
- Keywords
- Hypothermia, Newborn, Hyperthermia, Kangaroo mother care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 preterm infants (32-36 6/7 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 preterm infants (32-36 6/7 weeks of gestational age) when compared with routine WHO thermoregulation alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Continuous Kangaroo Mother Care to 1 hour after birth | Active comparator | Other: Continuous Kangaroo Mother Care to 1 hour after birthIn addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from birth to one hour after birth. |
| Standard Kangaroo Mother Care to 1 hour after birth | Sham comparator | Other: Standard Kangaroo Mother Care to 1 hour after birthInfants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from birth to 1 hour after birth. |
| Continuous Kangaroo Mother Care to discharge | Active comparator | Other: Continuous Kangaroo Mother Care to dischargeIn addition to standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia, the infants will receive continuous KMC most of the time possible from one hour after birth to discharge. |
| Standard Kangaroo Mother Care to discharge | Sham comparator | Other: Standard Kangaroo Mother Care to dischargeInfants will receive standard WHO thermoregulation care which includes warm delivery rooms, immediate drying, Kangaroo Mother Care (KMC) whenever possible, early and exclusive breastfeeding, postponed bathing and weighing if needed, appropriate bundling and placing the infant in air incubator, radiant heater, or heat mattress if the infant develops hypothermia from 1 hour after birth to discharge. |
Who may qualify
- Ages
- 1 minute to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Estimated gestational age 32-36 6/7 weeks
- Delivery in the hospital
Key exclusion criteria (3 listed)
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Kangaroo Mother Care to 1 hour after birthInfants 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. | Other | Continuous Kangaroo Mother Care to 1 hour after birth |
| Standard Kangaroo Mother Care to 1 hour after birthInfants 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. | Other | Standard Kangaroo Mother Care to 1 hour after birth |
| Continuous Kangaroo Mother Care to dischargeInfants 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. | Other | Continuous Kangaroo Mother Care to discharge |
| Standard Kangaroo Mother Care to dischargeInfants 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. | Other | Standard Kangaroo Mother Care to discharge |
Primary outcome
Axillary temperature < 36.0 degrees Celsius
Time frame: Time of birth to 1 hour
Temperature taken per axilla for one minute
Axillary Temperature < 36.0 degrees Celsius
Time frame: At discharge or 24 hours after birth (whichever is first)
Temperature taken per axilla for one minute
9 secondary outcomes
Blood pressure
Time frame: Duration of hospitalization-expected average of 4 weeks
Blood glucose
Time frame: Duration of hospitalization-expected average of 4 weeks
Seizure
Time frame: Duration of hospitalization-expected average of 4 weeks
Respiratory Distress Syndrome (RDS)
Time frame: Duration of hospitalization-expected average of 4 weeks
Sepsis
Time frame: Duration of hospitalization-expected average of 4 weeks
Neonatal Intensive Care Unit Admission
Time frame: Duration of hospitalization-expected average of 4 weeks
Death
Time frame: Duration of hospitalization-expected average of 4 weeks
Any Axillary Temperature < 36.0 degrees Celsius
Time frame: Duration of hospitalization-expected average of 4 weeks
Duration of Kangaroo Mother Care
Time frame: Duration of hospitalization-expected average 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waldemar A Carlo, MD study director
University of Alabama at Birmingham
Manimaran Ramani, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Kangaroo Mother Care to 1 hour after birth, Standard Kangaroo Mother Care to 1 hour after birth and Continuous Kangaroo Mother Care to discharge in people with Hypothermia, Newborn, run by University of Alabama at Birmingham at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary temperature < 36.0 degrees Celsius (time frame: Time of birth to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.