HypothermiaPhase 3NCT01671241
Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping
A Phase 3 study testing Polyethylene wrap in people with Hypothermia and Preterm Infant, run by University of Padova at 1 site in Italy.
Trial summary
Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants. Read more about this study
- Who is it for?
- Ages 1 minute to 3 minutes
- Conditions the study is for
- Hypothermia, Preterm Infant
- What is being tested?
- Polyethylene wrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to not given
- 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
- Preterm infants <29 weeks' gestation born in the study centers
Who cannot join
- Congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Padua, Azienda Ospedaliera di Padova
Padua, 35128
Daniele Trevisanuto, MD, 39 049 8213545, trevo@pediatria.unipd.it
Daniele Trevisanuto, MD
About this study
Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very preterm babies and represents the standard of care recommended by the International Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the proportions of hypothermic infants at NICU admission (temperature <34°C) in the wrapped group (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The combination of body and head protection with a polyethylene wrap needs to be evaluated further. The investigators conducted a prospective, randomized, controlled trial in very preterm infants to evaluate whether a polyethylene total body wrapping (body plus head) prevents heat loss after delivery better than polyethylene occlusive wrapping.
- Conditions
- Hypothermia, Preterm Infant
- Being tested
- Polyethylene wrap
- 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 wrapDevice
Polyethylene wrapDevice
| Study group | Role | What they receive |
|---|---|---|
| Total body polyethylene wrap (body plus head) | Experimental | The entire body surface (body plus head) is covered by a polyethylene wrap Receives: Device: Polyethylene wrap |
| Polyethylene wrap (body) | Active comparator | A polyethylene wrap covers the patient's body up to the neck Receives: Device: Polyethylene wrap |
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 total body wrap and wrap removal) and again 1 hour later
Secondary outcomes (3)
Mortality prior to hospital discharge
Major brain injury
percentages of hyperthermic infants at NICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies 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
- Prevention
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671241
- Sponsor's protocol ID
- LossPreventionTotalBodyWrap
- Status last verified
- Aug 2012
- First submitted
- 17 Jul 2012
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.
PubMed 15580195Vohra S, Frent G, Campbell V, Abbott M, Whyte R. Effect of polyethylene occlusive skin wrapping on heat loss in very low birth weight infants at delivery: a randomized trial. J Pediatr. 1999 May;134(5):547-51. doi: 10.1016/s0022-3476(99)70238-6.
PubMed 10228287Trevisanuto 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 20227728Doglioni N, Cavallin F, Mardegan V, Palatron S, Filippone M, Vecchiato L, Bellettato M, Chiandetti L, Trevisanuto D. Total body polyethylene wraps for preventing hypothermia in preterm infants: a randomized trial. J Pediatr. 2014 Aug;165(2):261-266.e1. doi: 10.1016/j.jpeds.2014.04.010. Epub 2014 May 14.
PubMed 24837862
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping
- ClinicalTrials.gov ID
- NCT01671241
- Acronym / sponsor ID
- LossPreventionTotalBodyWrap
- Conditions
- Hypothermia, Preterm Infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 23 Aug 2012 (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.
Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very preterm babies and represents the standard of care recommended by the International Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the proportions of hypothermic infants at NICU admission (temperature <34°C) in the wrapped group (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The combination of body and head protection with a polyethylene wrap needs to be evaluated further. The investigators conducted a prospective, randomized, controlled trial in very preterm infants to evaluate whether a polyethylene total body wrapping (body plus head) prevents heat loss after delivery better than polyethylene occlusive wrapping.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total body polyethylene wrap (body plus head) | Experimental | Device: Polyethylene wrapThe entire body surface (body plus head) is covered by a polyethylene wrap |
| Polyethylene wrap (body) | Active comparator | Device: Polyethylene wrapA polyethylene wrap covers the patient's body up to the neck |
Who may qualify
- Ages
- 1 minute to 3 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants <29 weeks' gestation born in the study centers
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 wrap | Device | Total body polyethylene wrap (body plus head) |
| Polyethylene wrap | Device | Polyethylene wrap (body) |
Primary outcome
Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later
3 secondary outcomes
Mortality prior to hospital discharge
Major brain injury
percentages of hyperthermic infants at NICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Background: PubMed 15580195Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.
- Background: PubMed 10228287Vohra S, Frent G, Campbell V, Abbott M, Whyte R. Effect of polyethylene occlusive skin wrapping on heat loss in very low birth weight infants at delivery: a randomized trial. J Pediatr. 1999 May;134(5):547-51. doi: 10.1016/s0022-3476(99)70238-6.
- Background: 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.
- Derived from this study: PubMed 24837862Doglioni N, Cavallin F, Mardegan V, Palatron S, Filippone M, Vecchiato L, Bellettato M, Chiandetti L, Trevisanuto D. Total body polyethylene wraps for preventing hypothermia in preterm infants: a randomized trial. J Pediatr. 2014 Aug;165(2):261-266.e1. doi: 10.1016/j.jpeds.2014.04.010. Epub 2014 May 14.
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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.
University of Padua, Azienda Ospedaliera di Padova
Padua, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyethylene wrap in people with Hypothermia and Preterm Infant, run by University of Padova at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 23 Aug 2012. 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 Italy. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later. 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 NCT01671241, which also lists 4 linked publications.
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 23 Aug 2012.