Preterm InfantNCT03141723
Kangaroo Mother Care With Plastic Bag (Trials 2A & 2B)
A study testing KMC & WHO protocol (0-1 hour), KMC, WHO protocol & bag (0-1 hour) and KMC & WHO protocol (1-24 hours) in people with Preterm Infant and Hypothermia Neonatal, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 10 minutes to 24 hours
- Conditions the study is for
- Preterm Infant, Hypothermia Neonatal
- What is being tested?
- KMC & WHO protocol (0-1 hour), KMC, WHO protocol & bag (0-1 hour) and KMC & WHO protocol (1-24 hours)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteZambia
- Study dates
- 19 May 2017to 12 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 10 minutes to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated gestational age ≥37 0/7 weeks
- Delivery in the hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 2A and 2B)
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.
Read the detailed description
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 term infants ≥ 37 0/7 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 and one for infants who are ≥37 weeks gestational age (this one). This term 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.
- Conditions
- Preterm Infant, Hypothermia Neonatal
- Being tested
- KMC & WHO protocol (0-1 hour), KMC, WHO protocol & bag (0-1 hour), KMC & WHO protocol (1-24 hours), KMC, WHO protocol & bag (1-24 hours)
- Keywords
- Infant, Newborn, Preterm, Hypothermia, Kangaroo, Plastic, Bag
- Medical subject headings
- Premature Birth, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KMC & WHO protocol (0-1 hour)Other
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
KMC, WHO protocol & bag (0-1 hour)Other
In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag] linear low-density bag measuring 10 × 8 × 24 in. and 1.2 mil thick) that will cover the infant's torso and lower extremities.
KMC & WHO protocol (1-24 hours)Other
WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive
KMC, WHO protocol & bag (1-24 hours)Other
In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag]
| Study group | Role | What they receive |
|---|---|---|
| KMC & WHO protocol (0-1 hour) | Active comparator | 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. Receives: Other: KMC & WHO protocol (0-1 hour) |
| KMC & WHO protocol (1-24 hours) | Active comparator | 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. Receives: Other: KMC & WHO protocol (1-24 hours) |
| KMC, WHO protocol & bag (0-1 hour) | Experimental | 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. Receives: Other: KMC, WHO protocol & bag (0-1 hour) |
| KMC, WHO protocol & bag (1-24 hours | Experimental | 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. Receives: Other: KMC, WHO protocol & bag (1-24 hours) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 hour after birth
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)
Measured: 1 to 24 hours after birth
Secondary outcomes (13)
Any hypothermia at 1 hour after birth (Phase 2A)
Any hypothermia (<36.5C) at 1 hour after birth
Measured: 1 hour after birth
Any hypothermia at 1 hour after birth (Phase 2B)
Any hypothermia (<36.5C) at 24 hours or discharge, whichever occurs first
Measured: 1 to 24 hours or discharge
Hyperthermia at 1 hour after birth (Phase 2A)
Hyperthermia (>38.0C) at 1 hour after birth
Measured: 1 hour after birth
Hyperthermia at 1 hour after birth (Phase 2B)
Hyperthermia (>38.0C) at 24 hours or discharge, whichever occurs first
Measured: 1 to 24 hours or discharge
Skin rash
Skin rash (at 1 hour and before discharge)
Measured: 1 hour 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)
Measured: 1 hour to 24 hours or discharge, or whichever occurs first
Respiratory distress syndrome
Diagnosis of respiratory distress syndrome (at 1 hour and before discharge)
Measured: 1 hour to 24 hours or discharge, or whichever occurs first
Sepsis
Diagnosis of sepsis (at 1 hour and before discharge)
Measured: 1 hour 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)
Measured: 1 hour to 24 hours or discharge, or whichever occurs first
Death
Death (at 1 hour and before discharge)
Measured: 1 hour to 24 hours or discharge, or whichever occurs first
Maternal body temperature
Maternal body temperature in Celsius
Measured: At birth, at 1 hour, and 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
Measured: 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
Measured: During first 24 hours or discharge, or whichever occurs first]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start19 May 2017
- Primary completion12 Aug 2017
- Study completion12 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies 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
- Model description
- Randomization at birth followed by randomization at 1 hour
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Colm P Travers, MD, Principal investigator, University of Alabama at BirminghamWaldemar A Carlo, MD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141723
- Sponsor's protocol ID
- F150807003
- Status last verified
- Jun 2018
- First submitted
- 3 May 2017
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Travers CP, Ramani M, Gentle SJ, Schuyler A, Brown C, Dills MM, Davis CB, Mwenechanya M, Chomba E, Aban I, Manasyan A, Ambalavanan N, Carlo WA. Early Skin-to-Skin Care with a Polyethylene Bag for Neonatal Hypothermia: A Randomized Clinical Trial. J Pediatr. 2021 Apr;231:55-60.e1. doi: 10.1016/j.jpeds.2020.12.064. Epub 2020 Dec 26.
PubMed 33373672
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trials of Kangaroo Mother Care With Plastic Bag to Prevent Neonatal Hypothermia in Preterm Infants (Trial 2A and 2B)
- ClinicalTrials.gov ID
- NCT03141723
- Acronym / sponsor ID
- F150807003
- Conditions
- Preterm Infant, Hypothermia Neonatal
- Keywords
- Infant, Newborn, Preterm, Hypothermia, Kangaroo, Plastic, Bag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia
- Study start
- 19 May 2017 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 12 Aug 2017 (actual)
- First posted
- 5 May 2017 (actual)
- 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 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.
Detailed description
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 term infants ≥ 37 0/7 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 and one for infants who are ≥37 weeks gestational age (this one). This term 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomization at birth followed by randomization at 1 hour
| Arm | Type | Receives |
|---|---|---|
| KMC & WHO protocol (0-1 hour) | Active comparator | 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. |
| KMC & WHO protocol (1-24 hours) | Active comparator | Other: KMC & WHO protocol (1-24 hours)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. |
| KMC, WHO protocol & bag (0-1 hour) | Experimental | 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. |
| KMC, WHO protocol & bag (1-24 hours | Experimental | Other: KMC, WHO protocol & bag (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. |
Who may qualify
- Ages
- 10 minutes to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Estimated gestational age ≥37 0/7 weeks
- Delivery in the hospital
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| KMC & WHO protocol (0-1 hour)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) |
| KMC, WHO protocol & bag (0-1 hour)In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag] linear low-density bag measuring 10 × 8 × 24 in. and 1.2 mil thick) that will cover the infant's torso and lower extremities. | Other | KMC, WHO protocol & bag (0-1 hour) |
| KMC & WHO protocol (1-24 hours)WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive | Other | KMC & WHO protocol (1-24 hours) |
| KMC, WHO protocol & bag (1-24 hours)In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag] | Other | KMC, WHO protocol & bag (1-24 hours |
Primary outcome
Moderate or severe hypothermia at 1 hour after birth (Phase 2A)
Time frame: 1 hour after birth
Moderate (32.0-35.9C) or severe (<32.0C) hypothermia at 1 hour after birth (via axillary temperature)
Moderate or severe hypothermia at 24 hours or discharge (Phase 2B)
Time frame: 1 to 24 hours after birth
Moderate (32.0-35.9C) or severe (<32.0C) hypothermia at 24 hours or discharge whichever occurs first (via axillary temperature)
13 secondary outcomes
Any hypothermia at 1 hour after birth (Phase 2A)
Time frame: 1 hour after birth
Any hypothermia at 1 hour after birth (Phase 2B)
Time frame: 1 to 24 hours or discharge
Hyperthermia at 1 hour after birth (Phase 2A)
Time frame: 1 hour after birth
Hyperthermia at 1 hour after birth (Phase 2B)
Time frame: 1 to 24 hours or discharge
Skin rash
Time frame: 1 hour to 24 hours or discharge, or whichever occurs first
Neonatal Intensive Care Unit admission
Time frame: 1 hour to 24 hours or discharge, or whichever occurs first
Respiratory distress syndrome
Time frame: 1 hour to 24 hours or discharge, or whichever occurs first
Sepsis
Time frame: 1 hour to 24 hours or discharge, or whichever occurs first
Hypotension, hypoglycemia or seizure
Time frame: 1 hour to 24 hours or discharge, or whichever occurs first
Death
Time frame: 1 hour to 24 hours or discharge, or whichever occurs first
Maternal body temperature
Time frame: At birth, at 1 hour, and every four hours until 24 hours or discharge, whichever occurs first
Duration of KMC and plastic bag to infant's body temperature
Time frame: During first 1 hour
Duration of KMC and plastic bag to infant's body temperature
Time frame: During first 24 hours or discharge, or whichever occurs first]
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 18 Jun 2018.
- Derived from this study: PubMed 33373672Travers CP, Ramani M, Gentle SJ, Schuyler A, Brown C, Dills MM, Davis CB, Mwenechanya M, Chomba E, Aban I, Manasyan A, Ambalavanan N, Carlo WA. Early Skin-to-Skin Care with a Polyethylene Bag for Neonatal Hypothermia: A Randomized Clinical Trial. J Pediatr. 2021 Apr;231:55-60.e1. doi: 10.1016/j.jpeds.2020.12.064. Epub 2020 Dec 26.
- Individual participant dataSharing planned: No
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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.
Colm P Travers, MD principal investigator
University of Alabama at Birmingham
Waldemar A Carlo, MD study director
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 KMC & WHO protocol (0-1 hour), KMC, WHO protocol & bag (0-1 hour) and KMC & WHO protocol (1-24 hours) in people with Preterm Infant and Hypothermia Neonatal, 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 8 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 18 Jun 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. 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?
Moderate or severe hypothermia at 1 hour after birth (Phase 2A) (time frame: 1 hour after birth). 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 NCT03141723, 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 18 Jun 2018.