HypothermiaNCT02189759
Kangaroo Mother Care to Prevent Hypothermia in Term Infants
A study testing Continuous Kangaroo Mother Care to one hour after birth, Standard Kangaroo Mother Care to one hour after birth and Continuous Kangaroo Mother Care to discharge in people with Hypothermia and 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 term infants (greater than or equal to 37 weeks of gestational age) when… Read more about this study
- Who is it for?
- Ages 1 minute to 2 weeks
- Conditions the study is for
- Hypothermia, Newborn
- What is being tested?
- Continuous Kangaroo Mother Care to one hour after birth, Standard Kangaroo Mother Care to one 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
- 375 participants
- Where
- 1 siteZambia
- Study dates
- Aug 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated gestational age greater than or equal to 37 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 Prent Neonatal Hypothermia - Trials 2A & 2 B
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.
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 term infants (greater than or equal to weeks of gestational age) when compared with routine WHO thermoregulation alone.
- Conditions
- Hypothermia, Newborn
- Being tested
- Continuous Kangaroo Mother Care to one hour after birth, Standard Kangaroo Mother Care to one hour after birth, Continuous Kangaroo Mother Care to discharge, Standard Kangaroo Mother Care to discharge
- Keywords
- Hypothermia, Hyperthermia, Kangaroo Mother Care, Newborn
- 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 one 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 one 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 one 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 one hour after birth |
| Standard Kangaroo Mother Care to one 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 one 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.
Number of Infants With Axillary Temperature <36.0 Degrees Celsius
Temperature taken per axilla using digital thermometer
Measured: Time of birth to 1 hour
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
Measured: At discharge or 24 hours after birth (whichever is first)
Secondary outcomes (2)
Number Infants Admitted to the Neonatal Intensive Care Unit
Any admission to the neonatal intensive care unit for higher level care
Measured: Duration of hospitalization-an average of 2 weeks
Duration of Kangaroo Mother Care
Skin to skin contact between baby and mother
Measured: Duration of hospitalization-an average of 2 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 startAug 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies 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
- 375 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
- NCT02189759
- Sponsor's protocol ID
- UAB Neo 012
- Status last verified
- Apr 2017
- First submitted
- 11 Jul 2014
- Last updated
- 19 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ramani M, Choe EA, Major M, Newton R, Mwenechanya M, Travers CP, Chomba E, Ambalavanan N, Carlo WA. Kangaroo mother care for the prevention of neonatal hypothermia: a randomised controlled trial in term neonates. Arch Dis Child. 2018 May;103(5):492-497. doi: 10.1136/archdischild-2017-313744. Epub 2018 Feb 22.
PubMed 29472198
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Kangaroo Mother Care to Prent Neonatal Hypothermia - Trials 2A & 2 B
- ClinicalTrials.gov ID
- NCT02189759
- Acronym / sponsor ID
- UAB Neo 012
- Conditions
- Hypothermia, Newborn
- Keywords
- Hypothermia, Hyperthermia, Kangaroo Mother Care, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Posted 19 Jun 2017
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 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.
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 one hour after birth | Active comparator | Other: Continuous Kangaroo Mother Care to one 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 one hour after birth | Sham comparator | Other: Standard Kangaroo Mother Care to one 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 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Estimated gestational age greater than or equal to 37 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 one 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 one hour after birth |
| Standard Kangaroo Mother Care to one 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 one 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
Number of Infants With Axillary Temperature <36.0 Degrees Celsius
Time frame: 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
Time frame: At discharge or 24 hours after birth (whichever is first)
Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth
2 secondary outcomes
Number Infants Admitted to the Neonatal Intensive Care Unit
Time frame: Duration of hospitalization-an average of 2 weeks
Duration of Kangaroo Mother Care
Time frame: Duration of hospitalization-an average of 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29472198Ramani M, Choe EA, Major M, Newton R, Mwenechanya M, Travers CP, Chomba E, Ambalavanan N, Carlo WA. Kangaroo mother care for the prevention of neonatal hypothermia: a randomised controlled trial in term neonates. Arch Dis Child. 2018 May;103(5):492-497. doi: 10.1136/archdischild-2017-313744. Epub 2018 Feb 22.
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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 one hour after birth, Standard Kangaroo Mother Care to one hour after birth and Continuous Kangaroo Mother Care to discharge in people with Hypothermia and 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 19 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Infants With 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?
On the ClinicalTrials.gov record for NCT02189759, which also lists 1 linked publication.
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 19 Jun 2017.