Hypothermia, Preterm InfantsPhase 3NCT00930917
Heat Loss Prevention in Delivery Room Using a Polyethylene Cap
A Phase 3 study testing Polyethylene cap, Polyethylene wrap and conventional treatment in people with Hypothermia, Preterm Infants, run by University of Padova.
Trial summary
It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss. Read more about this study
- Who is it for?
- Ages 1 minute to 3 minutes
- Conditions the study is for
- Hypothermia, Preterm Infants
- What is being tested?
- Polyethylene cap, Polyethylene wrap and conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Feb 2009
- Phase
- Phase 3
- 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 3 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants <29 weeks' gestation born in the study center.
Who cannot join
- congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.
About this study
Official title: Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants
It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss.
We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap prevents postnatal heat loss.
Read the detailed description
The primary outcome measure was axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. Axillary temperature was measured using a digital thermometer (Terumo Digital Clinical Thermometer C202, Terumo Corporation, Tokio, Japan). The occurrence of hypothermia, defined as axillary temperature less then 36.4°C, on NICU admission was also evaluated.
Secondary outcomes included mortality prior to hospital discharge, presence of major brain injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation, parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
- Conditions
- Hypothermia, Preterm Infants
- Being tested
- Polyethylene cap, Polyethylene wrap, conventional treatment
- Keywords
- delivery room, polyethylene cap, preterm infant, temperature
- Medical subject headings
- Hypothermia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene capDevice
In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth
Polyethylene wrapDevice
Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried.
conventional treatmentOther
Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| cap | Experimental | In the cap group, the head of the infant was covered with a polyethylene cap immediately after birth Receives: Device: Polyethylene cap |
| wrap | Active comparator | Infants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried. Receives: Device: Polyethylene wrap |
| conventional group | Other | Infants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation. Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.
Measured: Admission to the NICU
Secondary outcomes (1)
Mortality prior to hospital discharge, presence of major brain injury, tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
Measured: NICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startDec 2007
- Primary completionFeb 2009
- Study completionFeb 2009
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 Hypothermia, Preterm InfantsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Investigators
- Daniele Trevisanuto, MD, Principal investigator, Azienda Ospedaliera of Padua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930917
- Sponsor's protocol ID
- NIDA8
- Status last verified
- Jun 2009
- First submitted
- 30 Jun 2009
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Trevisanuto D, Doglioni N, Cavallin F, Parotto M, Micaglio M, Zanardo V. Heat loss prevention in very preterm infants in delivery rooms: a prospective, randomized, controlled trial of polyethylene caps. J Pediatr. 2010 Jun;156(6):914-917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15.
PubMed 20227728
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Loss Prevention in Delivery Room: a Prospective, Randomised, Controlled Trial of Polyethylene Caps in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT00930917
- Acronym / sponsor ID
- NIDA8
- Conditions
- Hypothermia, Preterm Infants
- Keywords
- delivery room, polyethylene cap, preterm infant, temperature
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 Jul 2009 (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.
It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss.
We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap prevents postnatal heat loss.
Detailed description
The primary outcome measure was axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. Axillary temperature was measured using a digital thermometer (Terumo Digital Clinical Thermometer C202, Terumo Corporation, Tokio, Japan). The occurrence of hypothermia, defined as axillary temperature less then 36.4°C, on NICU admission was also evaluated.
Secondary outcomes included mortality prior to hospital discharge, presence of major brain injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation, parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cap | Experimental | Device: Polyethylene capIn the cap group, the head of the infant was covered with a polyethylene cap immediately after birth |
| wrap | Active comparator | Device: Polyethylene wrapInfants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried. |
| conventional group | Other | Other: conventional treatmentInfants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation. |
Who may qualify
- Ages
- 1 minute to 3 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants <29 weeks' gestation born in the study center.
Key exclusion criteria (1 listed)
- congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.
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 |
|---|---|---|
| Polyethylene capIn the cap group, the head of the infant was covered with a polyethylene cap immediately after birth | Device | cap |
| Polyethylene wrapInfants in the wrap group were placed into the polyethylene bag, while still wet, up to their necks; only the head was dried. | Device | wrap |
| conventional treatmentInfants in the control group were dried completely, according to International Guidelines for Neonatal Resuscitation. | Other | conventional group |
Primary outcome
Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later.
Time frame: Admission to the NICU
1 secondary outcome
Mortality prior to hospital discharge, presence of major brain injury, tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.
Time frame: NICU discharge
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 2 Jul 2009.
- Derived from this study: PubMed 20227728Trevisanuto D, Doglioni N, Cavallin F, Parotto M, Micaglio M, Zanardo V. Heat loss prevention in very preterm infants in delivery rooms: a prospective, randomized, controlled trial of polyethylene caps. J Pediatr. 2010 Jun;156(6):914-917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15.
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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.
Daniele Trevisanuto, MD principal investigator
Azienda Ospedaliera of Padua
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyethylene cap, Polyethylene wrap and conventional treatment in people with Hypothermia, Preterm Infants, run by University of Padova.
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 1 inclusion and 1 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 2 Jul 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. (time frame: Admission to the NICU). 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 NCT00930917, 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 2 Jul 2009.