Infant, PrematureCCotNCT03344978
Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial
A study testing Cardboard Cot Care and Incubator Care in people with Infant, Premature and Hypothermia, Newborn, run by University of Alabama at Birmingham.
Trial summary
This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C) in preterm neonates <36 6/7 weeks gestational age in a randomized cross-over designed trial. Read more about this study
- Who is it for?
- Ages 1 minute to 5 days
- Conditions the study is for
- Infant, Premature, Hypothermia, Newborn
- What is being tested?
- Cardboard Cot Care and Incubator Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Jun 2019to 27 Sep 2021
- 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 5 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Estimated gestational age < 36 6/7 weeks
- Hospitalized in the NICU at University Teaching Hospital in Zambia
- Requiring incubator/radiant warmer for at least 1 week
Who cannot join
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
- Suspected Sepsis
- Requiring ongoing respiratory support
About this study
Official title: Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial in Prevention of Moderate or Severe Hypothermia in Preterm Infants Requiring at Least 1 Week of Incubator
This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C) in preterm neonates <36 6/7 weeks gestational age in a randomized cross-over designed trial. Infants will be randomized to receive care in the cardboard cot or incubator and then cross over to the other device for 24 hour periods, rotating for a total of 96 hours total trial time.
Read the detailed description
The aim of the trial is to determine whether a corrugated cardboard cot will assist in maintaining infant axillary temperatures comparing it to the temperatures of the same infant being nursed in low heat incubators. The study will be done in the context of standard medical care, including the WHO thermoregulation protocol (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling).
The cardboard cot is approximately 24 inches long to accommodate the length of the infant and about 12 inches wide to accommodate term infants, even beyond the first months after birth. The cots are fully lined with a reflective metallized film sheet of Mylar. The cot will be covered with a cardboard piece also lined in reflective film up to about the infant's shoulders so that the infant's face is visible. Attached to the lid is a 5 inch cardboard flap lined with reflective film which folds down into the body of the cot to reduce heat loss.
Infants ≤ 36 6/7 weeks gestation will be randomized to receive care in a cardboard cot or an incubator. Infants will begin care in one device and after 24 hours will cross over to the other device for another 24 hours. The process will be repeated once more for a total of 96 hours of study duration. The infants will be normothermic and stable when they are enrolled in the trial. Axillary temperatures will be measured at 1 hr, 6 hours and 24 hours after being placed in the cost or incubator. Infants with observed hypothermia (<36° C) will have measures taken to increase temperature (i.e. adding blankets, hat).
- Conditions
- Infant, Premature, Hypothermia, Newborn
- Being tested
- Cardboard Cot Care, Incubator Care
- Keywords
- Neonate, Premature, Hypothermia, Cardboard, Cot
- 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.
Cardboard Cot CareOther
Also called CCot
Infant maintained in reflective film-lined cot for a period of 24 hours. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after randomization. If temperatures found < 36° C. at any time, an additional blanket and hat will be added to infant to improve temperature. Infant may be moved to incubator or radiant warmer. All other care will be standard of care at University Teaching Hospital, including warm delivery rooms, immediate drying, postponed bathing and weighing, early and exclusive breastfeeding, and Kangaroo Mother Care as continuously as possible.
Incubator CareOther
Infant maintained in standard incubator for a period of 24 hours. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after randomization. If temperatures found < 36° C. at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including warm delivery rooms, immediate drying, postponed bathing and weighing, early and exclusive breastfeeding, and Kangaroo Mother Care as continuously as possible.
| Study group | Role | What they receive |
|---|---|---|
| Cardboard Cot Care | Active comparator | Stable infant will be nursed in a cardboard cot, lined with reflective film for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Incubator Care), and back for a total of 2 24-hour periods in each arm. Receives: Other: Cardboard Cot Care |
| Incubator Care | Placebo comparator | Stable infant will be nursed in an incubator for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Cardboard Cot Care), and back for a total of 2 24-hour periods in each arm. Receives: Other: Incubator Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
Temperature taken via axilla for 1 minute duration
Measured: 1 hour after placement in warming device
Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
Temperature taken via axilla for 1 minute duration
Measured: 6 hours after placement in warming device
Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature
Temperature taken via axilla for 1 minute duration
Measured: 24 hours after placement in warming device
Secondary outcomes (10)
Normothermia (Axillary temperature 36.0 - 38.0° C)
Temperature taken via axilla for 1 minute duration
Measured: 1-96 hours after beginning of study
Hypothermia (Axillary temperature < 36.0° C)
Temperature taken via axilla for 1 minute duration
Measured: 1-96 hours after beginning of study
Mean Axillary Temperature in each device
Average of all axillary temperatures taken per device
Measured: 4 months
Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device
Temperature taken via axilla for 1 minute duration
Measured: 1 hour after placement in warming device
Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device
Temperature taken via axilla for 1 minute duration
Measured: 6 hours after placement in warming device
Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device
Temperature taken via axilla for 1 minute duration
Measured: 24 hours after placement in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Temperature taken via axilla for 1 minute duration
Measured: 1 hour after placemnt in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Temperature taken via axilla for 1 minute duration
Measured: 6 hours after placement in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Temperature taken via axilla for 1 minute duration
Measured: 24 hours after placement in warming device
Rate of Hyperthermia (>38.0°C) after placement in warming device
Temperature taken via axilla for 1 minute duration
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start11 Jun 2019
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies 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
- Crossover
- Model description
- Randomized crossover. Participant will be randomly assigned initially to care in one of two devices for 24 hours, then crossed over to other device for 24 hours. This will be repeated once more for a total of 96 hours study time. Patterns may be A-B-A-B or B-A-B-A.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Colm P Travers, MB BCh BAO, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344978
- Sponsor's protocol ID
- UAB Neo 018
- Acronym
- CCot
- Status last verified
- Oct 2021
- First submitted
- 14 Nov 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial in Prevention of Moderate or Severe Hypothermia in Preterm Infants Requiring at Least 1 Week of Incubator
- ClinicalTrials.gov ID
- NCT03344978
- Acronym / sponsor ID
- CCot / UAB Neo 018
- Conditions
- Infant, Premature, Hypothermia, Newborn
- Keywords
- Neonate, Premature, Hypothermia, Cardboard, Cot
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 17 Nov 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.
This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature < 36° C) in preterm neonates <36 6/7 weeks gestational age in a randomized cross-over designed trial. Infants will be randomized to receive care in the cardboard cot or incubator and then cross over to the other device for 24 hour periods, rotating for a total of 96 hours total trial time.
Detailed description
The aim of the trial is to determine whether a corrugated cardboard cot will assist in maintaining infant axillary temperatures comparing it to the temperatures of the same infant being nursed in low heat incubators. The study will be done in the context of standard medical care, including the WHO thermoregulation protocol (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling).
The cardboard cot is approximately 24 inches long to accommodate the length of the infant and about 12 inches wide to accommodate term infants, even beyond the first months after birth. The cots are fully lined with a reflective metallized film sheet of Mylar. The cot will be covered with a cardboard piece also lined in reflective film up to about the infant's shoulders so that the infant's face is visible. Attached to the lid is a 5 inch cardboard flap lined with reflective film which folds down into the body of the cot to reduce heat loss.
Infants ≤ 36 6/7 weeks gestation will be randomized to receive care in a cardboard cot or an incubator. Infants will begin care in one device and after 24 hours will cross over to the other device for another 24 hours. The process will be repeated once more for a total of 96 hours of study duration. The infants will be normothermic and stable when they are enrolled in the trial. Axillary temperatures will be measured at 1 hr, 6 hours and 24 hours after being placed in the cost or incubator. Infants with observed hypothermia (<36° C) will have measures taken to increase temperature (i.e. adding blankets, hat).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover. Participant will be randomly assigned initially to care in one of two devices for 24 hours, then crossed over to other device for 24 hours. This will be repeated once more for a total of 96 hours study time. Patterns may be A-B-A-B or B-A-B-A.
| Arm | Type | Receives |
|---|---|---|
| Cardboard Cot Care | Active comparator | Other: Cardboard Cot CareStable infant will be nursed in a cardboard cot, lined with reflective film for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Incubator Care), and back for a total of 2 24-hour periods in each arm. |
| Incubator Care | Placebo comparator | Other: Incubator CareStable infant will be nursed in an incubator for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Cardboard Cot Care), and back for a total of 2 24-hour periods in each arm. |
Who may qualify
- Ages
- 1 minute to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Estimated gestational age < 36 6/7 weeks
- Hospitalized in the NICU at University Teaching Hospital in Zambia
- Requiring incubator/radiant warmer for at least 1 week
Key exclusion criteria (5 listed)
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
- Suspected Sepsis
- Requiring ongoing respiratory support
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 |
|---|---|---|
| Cardboard Cot CareAlso: CCotInfant maintained in reflective film-lined cot for a period of 24 hours. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after randomization. If temperatures found < 36° C. at any time, an additional blanket and hat will be added to infant to improve temperature. Infant may be moved to incubator or radiant warmer. All other care will be standard of care at University Teaching Hospital, including warm delivery rooms, immediate drying, postponed bathing and weighing, early and exclusive breastfeeding, and Kangaroo Mother Care as continuously as possible. | Other | Cardboard Cot Care |
| Incubator CareInfant maintained in standard incubator for a period of 24 hours. Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after randomization. If temperatures found < 36° C. at any time, an additional blanket and hat will be added to infant to improve temperature. All other care will be standard of care at University Teaching Hospital, including warm delivery rooms, immediate drying, postponed bathing and weighing, early and exclusive breastfeeding, and Kangaroo Mother Care as continuously as possible. | Other | Incubator Care |
Primary outcome
Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
Time frame: 1 hour after placement in warming device
Temperature taken via axilla for 1 minute duration
Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature
Time frame: 6 hours after placement in warming device
Temperature taken via axilla for 1 minute duration
Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature
Time frame: 24 hours after placement in warming device
Temperature taken via axilla for 1 minute duration
10 secondary outcomes
Normothermia (Axillary temperature 36.0 - 38.0° C)
Time frame: 1-96 hours after beginning of study
Hypothermia (Axillary temperature < 36.0° C)
Time frame: 1-96 hours after beginning of study
Mean Axillary Temperature in each device
Time frame: 4 months
Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device
Time frame: 1 hour after placement in warming device
Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device
Time frame: 6 hours after placement in warming device
Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device
Time frame: 24 hours after placement in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Time frame: 1 hour after placemnt in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Time frame: 6 hours after placement in warming device
Rate of Severe hypothermia (<32.0° C) after placement in warming device
Time frame: 24 hours after placement in warming device
Rate of Hyperthermia (>38.0°C) after placement in warming device
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- 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, MB BCh BAO principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Cardboard Cot Care and Incubator Care in people with Infant, Premature and Hypothermia, Newborn, run by University of Alabama at Birmingham.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature (time frame: 1 hour after placement in warming device). The study lists 3 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 26 Oct 2021; AzTrials last refreshed its copy on 1 Nov 2026.