Hypothermia NeonatalNCT07661511
Polyethylene Bag vs Prewarmed Blanket for Preventing Neonatal Hypothermia During Transfer
A study testing Neonatal Polyethylene Bag and Prewarmed Blanket in people with Hypothermia Neonatal and Premature Birth, run by Mario Adrián Tienda Vázquez at 1 site in Mexico.
Trial summary
Premature babies can lose body heat quickly after birth, which can lead to serious health problems. This study compared two methods to keep premature babies warm while they were being moved from the delivery room to the neonatal intensive care unit (NICU): wrapping the baby in a plastic bag (polyethylene bag) versus… Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Hypothermia Neonatal, Premature Birth, Neonatal
- What is being tested?
- Neonatal Polyethylene Bag and Prewarmed Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteMexico
- Study dates
- 25 Nov 2025to 17 Feb 2026
- 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 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature neonates born before 37 weeks of gestation
- Birth weight ≤2000 grams
- Born in the obstetric-surgical unit of the participating public hospital and requiring immediate intrahospital transfer to the Neonatal Intensive Care Unit (NICU)
- Written informed consent provided by parents or legal guardians
Who cannot join
- Major congenital malformations
- Need for immediate resuscitation procedures incompatible with application of the assigned intervention
- Parents or legal guardians unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Polyethylene Bag Compared With a Prewarmed Blanket for Preventing Hypothermia During Intrahospital Transfer in Premature Neonates: A Randomized Pilot Clinical Trial
Premature babies can lose body heat quickly after birth, which can lead to serious health problems. This study compared two methods to keep premature babies warm while they were being moved from the delivery room to the neonatal intensive care unit (NICU): wrapping the baby in a plastic bag (polyethylene bag) versus wrapping the baby in a prewarmed blanket, which is the usual method used in many hospitals. Sixty-seven premature babies weighing 2000 grams or less were randomly assigned to receive one of these two methods. The researchers measured the babies' body temperature, heart rate, oxygen levels, and blood sugar at three points: right after birth, during the transfer, and after arriving at the NICU. The goal was to find out whether the plastic bag method was more effective than the blanket method at preventing low body temperature (hypothermia) in these vulnerable babies.
Read the detailed description
Neonatal hypothermia is a major contributor to morbidity and mortality in premature infants, particularly during the period immediately following birth and during intrahospital transfer to the neonatal intensive care unit (NICU). International guidelines, including those from the World Health Organization and the Neonatal Resuscitation Program of the American Academy of Pediatrics, recommend thermal protection strategies such as the use of polyethylene bags or wraps in very low birth weight infants. However, most prior studies evaluating this intervention have not clearly differentiated outcomes by birth weight, and have primarily focused on body temperature as an outcome, with limited evaluation of other physiological parameters such as heart rate, oxygen saturation, and capillary blood glucose.
This randomized, open-label, parallel-group pilot clinical trial was conducted in the obstetric-surgical unit of a public hospital in Querétaro, Mexico. Sixty-seven premature neonates born before 37 weeks of gestation and weighing 2000 grams or less, who required immediate transfer to the NICU, were randomly assigned to an intervention group (n=33), in which a neonatal polyethylene bag was applied immediately after birth and maintained throughout intrahospital transfer, or a control group (n=34), in which the neonate was dried and wrapped in a prewarmed blanket according to standard unit protocol.
Axillary body temperature, heart rate, oxygen saturation, and capillary blood glucose were measured at three time points: within the first minute of life (baseline), during intrahospital transfer, and five minutes after NICU admission. The primary outcome was the frequency of hypothermia, defined as axillary temperature below 36.5°C, at NICU admission. Secondary outcomes included changes in heart rate, oxygen saturation, and capillary blood glucose between baseline and NICU admission.
Statistical analyses included comparison of baseline characteristics between groups, repeated-measures ANOVA to assess temporal variation of physiological parameters, and binary logistic regression and ANCOVA models adjusted for birth weight and gestational age to account for baseline imbalances between groups. This pilot study aims to provide preliminary evidence on the effectiveness and safety of the polyethylene bag intervention to inform the design of future, larger confirmatory trials.
- Conditions
- Hypothermia Neonatal, Premature Birth, Neonatal
- Being tested
- Neonatal Polyethylene Bag, Prewarmed Blanket
- Keywords
- Polyethylene Bag, Intrahospital Transfer, Thermoregulation, Neonatal Intensive Care, Very Low Birth Weight
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal Polyethylene BagDevice
A neonatal polyethylene bag (Neohelp®, Vygon, France) placed around the infant's body immediately after birth, without prior drying, to reduce evaporative and convective heat loss during intrahospital transfer to the neonatal intensive care unit.
Prewarmed BlanketOther
Standard thermal management consisting of drying the neonate immediately after birth and wrapping in a blanket prewarmed to 37°C, used as the unit's conventional approach during intrahospital transfer to the neonatal intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene Bag | Experimental | Premature neonates weighing ≤2000 g assigned to this arm were placed inside a neonatal polyethylene bag (Neohelp®, Vygon, France) immediately after birth, without prior drying, covering the body up to the neck with the integrated head cap adjusted. The bag was maintained throughout intrahospital transfer until NICU admission. Receives: Device: Neonatal Polyethylene Bag |
| Prewarmed Blanket | Active comparator | Premature neonates weighing ≤2000 g assigned to this arm were dried immediately after birth and wrapped in a prewarmed blanket (37°C), in accordance with the unit's conventional thermal management protocol during intrahospital transfer to the NICU. Receives: Other: Prewarmed Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Neonatal Hypothermia at NICU Admission
Proportion of neonates with axillary body temperature below 36.5°C at NICU admission.
Measured: At NICU admission, approximately 5 minutes after arrival
Secondary outcomes (3)
Change in Heart Rate from Baseline to NICU Admission
Difference in heart rate (beats per minute) between baseline measurement (first minute of life) and measurement at NICU admission.
Measured: From first minute of life to NICU admission
Change in Oxygen Saturation from Baseline to NICU Admission
Difference in peripheral oxygen saturation (%) between baseline measurement (first minute of life) and measurement at NICU admission.
Measured: From first minute of life to NICU admission
Change in Capillary Blood Glucose from Baseline to NICU Admission
Difference in capillary blood glucose level (mg/dL) between baseline measurement (first minute of life) and measurement at NICU admission.
Measured: From first minute of life to NICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start25 Nov 2025
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia NeonatalStudies of the same condition, open and under way.
- 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
- Participants were randomly assigned to one of two parallel groups: polyethylene bag (intervention) or prewarmed blanket (control), with no crossover between groups.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Adrián Tienda Vázquez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Adrián Tienda Vázquez, Universidad Autonoma de Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661511
- Sponsor's protocol ID
- COMBIOENF-006-2025-ME
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Polyethylene Bag Compared With a Prewarmed Blanket for Preventing Hypothermia During Intrahospital Transfer in Premature Neonates: A Randomized Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07661511
- Acronym / sponsor ID
- COMBIOENF-006-2025-ME
- Conditions
- Hypothermia Neonatal, Premature Birth, Neonatal
- Keywords
- Polyethylene Bag, Intrahospital Transfer, Thermoregulation, Neonatal Intensive Care, Very Low Birth Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mario Adrián Tienda VázquezUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 22 Jun 2026 (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.
Premature babies can lose body heat quickly after birth, which can lead to serious health problems. This study compared two methods to keep premature babies warm while they were being moved from the delivery room to the neonatal intensive care unit (NICU): wrapping the baby in a plastic bag (polyethylene bag) versus wrapping the baby in a prewarmed blanket, which is the usual method used in many hospitals. Sixty-seven premature babies weighing 2000 grams or less were randomly assigned to receive one of these two methods. The researchers measured the babies' body temperature, heart rate, oxygen levels, and blood sugar at three points: right after birth, during the transfer, and after arriving at the NICU. The goal was to find out whether the plastic bag method was more effective than the blanket method at preventing low body temperature (hypothermia) in these vulnerable babies.
Detailed description
Neonatal hypothermia is a major contributor to morbidity and mortality in premature infants, particularly during the period immediately following birth and during intrahospital transfer to the neonatal intensive care unit (NICU). International guidelines, including those from the World Health Organization and the Neonatal Resuscitation Program of the American Academy of Pediatrics, recommend thermal protection strategies such as the use of polyethylene bags or wraps in very low birth weight infants. However, most prior studies evaluating this intervention have not clearly differentiated outcomes by birth weight, and have primarily focused on body temperature as an outcome, with limited evaluation of other physiological parameters such as heart rate, oxygen saturation, and capillary blood glucose.
This randomized, open-label, parallel-group pilot clinical trial was conducted in the obstetric-surgical unit of a public hospital in Querétaro, Mexico. Sixty-seven premature neonates born before 37 weeks of gestation and weighing 2000 grams or less, who required immediate transfer to the NICU, were randomly assigned to an intervention group (n=33), in which a neonatal polyethylene bag was applied immediately after birth and maintained throughout intrahospital transfer, or a control group (n=34), in which the neonate was dried and wrapped in a prewarmed blanket according to standard unit protocol.
Axillary body temperature, heart rate, oxygen saturation, and capillary blood glucose were measured at three time points: within the first minute of life (baseline), during intrahospital transfer, and five minutes after NICU admission. The primary outcome was the frequency of hypothermia, defined as axillary temperature below 36.5°C, at NICU admission. Secondary outcomes included changes in heart rate, oxygen saturation, and capillary blood glucose between baseline and NICU admission.
Statistical analyses included comparison of baseline characteristics between groups, repeated-measures ANOVA to assess temporal variation of physiological parameters, and binary logistic regression and ANCOVA models adjusted for birth weight and gestational age to account for baseline imbalances between groups. This pilot study aims to provide preliminary evidence on the effectiveness and safety of the polyethylene bag intervention to inform the design of future, larger confirmatory trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: polyethylene bag (intervention) or prewarmed blanket (control), with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Polyethylene Bag | Experimental | Device: Neonatal Polyethylene BagPremature neonates weighing ≤2000 g assigned to this arm were placed inside a neonatal polyethylene bag (Neohelp®, Vygon, France) immediately after birth, without prior drying, covering the body up to the neck with the integrated head cap adjusted. The bag was maintained throughout intrahospital transfer until NICU admission. |
| Prewarmed Blanket | Active comparator | Other: Prewarmed BlanketPremature neonates weighing ≤2000 g assigned to this arm were dried immediately after birth and wrapped in a prewarmed blanket (37°C), in accordance with the unit's conventional thermal management protocol during intrahospital transfer to the NICU. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature neonates born before 37 weeks of gestation
- Birth weight ≤2000 grams
- Born in the obstetric-surgical unit of the participating public hospital and requiring immediate intrahospital transfer to the Neonatal Intensive Care Unit (NICU)
- Written informed consent provided by parents or legal guardians
Key exclusion criteria (3 listed)
- Major congenital malformations
- Need for immediate resuscitation procedures incompatible with application of the assigned intervention
- Parents or legal guardians unable or unwilling to provide informed consent
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 |
|---|---|---|
| Neonatal Polyethylene BagA neonatal polyethylene bag (Neohelp®, Vygon, France) placed around the infant's body immediately after birth, without prior drying, to reduce evaporative and convective heat loss during intrahospital transfer to the neonatal intensive care unit. | Device | Polyethylene Bag |
| Prewarmed BlanketStandard thermal management consisting of drying the neonate immediately after birth and wrapping in a blanket prewarmed to 37°C, used as the unit's conventional approach during intrahospital transfer to the neonatal intensive care unit. | Other | Prewarmed Blanket |
Primary outcome
Frequency of Neonatal Hypothermia at NICU Admission
Time frame: At NICU admission, approximately 5 minutes after arrival
Proportion of neonates with axillary body temperature below 36.5°C at NICU admission.
3 secondary outcomes
Change in Heart Rate from Baseline to NICU Admission
Time frame: From first minute of life to NICU admission
Change in Oxygen Saturation from Baseline to NICU Admission
Time frame: From first minute of life to NICU admission
Change in Capillary Blood Glucose from Baseline to NICU Admission
Time frame: From first minute of life to NICU admission
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 22 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neonatal Polyethylene Bag and Prewarmed Blanket in people with Hypothermia Neonatal and Premature Birth, run by Mario Adrián Tienda Vázquez at 1 site in Mexico.
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 4 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 22 Jun 2026. 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 Mexico. 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?
Frequency of Neonatal Hypothermia at NICU Admission (time frame: At NICU admission, approximately 5 minutes after arrival). 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 22 Jun 2026.