Temperature Regulation; Disorder, Fetus or NewbornNEODRYNCT05740072
Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth
A study testing Drying before wrapping and No drying before wrapping in people with Temperature Regulation; Disorder, Fetus or Newborn, run by University Hospital Padova at 1 site in Italy.
Trial summary
This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at… Read more about this study
- Who is it for?
- Ages 0 minutes to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Temperature Regulation; Disorder, Fetus or Newborn
- What is being tested?
- Drying before wrapping and No drying before wrapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2023to 31 Oct 2023
- 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 minutes to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Estimated birth weight <1500 g and/or gestational age ≤30+6 weeks (and)
- Inborn (and)
- Parental consent; written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian at the maternal admission to the Obstetric Department.
Who cannot join
- Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
- Outborn;
- Parental refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth: a Multicenter, Randomized Controlled Trial
This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.
Read the detailed description
Background: Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge.
A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. While drying is recommended for the thermal management of infants with gestational age >32 weeks, this procedure is not indicated for very preterm infants who should be put in a plastic wrap immediately at birth without drying. However, such indication is based on studies comparing wrapping without drying vs. drying without wrapping, while the potential advantages of combining these interventions were not explored. We hypothesized that drying before wrapping could prevent heat loss immediately after birth and reduce hypothermia at NICU admission in very preterm infants.
Objective: The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.
Methods: This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. After obtaining parental consent, all infants with estimated birth weight <1500 g and/or gestational age ≤30+6 weeks will be assigned to be managed with or without drying before plastic wrapping. Room temperature and maternal temperature will be measured at the time of delivery. Patients allocated in both groups will be managed based on the current guidelines for neonatal resuscitation. The primary outcome measure will be the proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. Secondary outcome measures will be: proportion of neonates with hypothermia (<36.5°C and <36.0°C) at NICU admission; proportion of hyperthermic neonates (temperature >37.5°C) at NICU admission; temperature at 1 hour after NICU admission; proportion of intraventricular hemorrhage; proportion of respiratory distress syndrome; proportion of late onset sepsis; proportion of bronchopulmonary dysplasia; mortality before hospital discharge.
- Being tested
- Drying before wrapping, No drying before wrapping
- Keywords
- Newborn, Prematurity, Temperature, Delivery
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drying before wrappingOther
Immediately after birth, the infant's body will be dried before wrapping in a plastic bag
No drying before wrappingOther
Immediately after birth, the infant will be put in a plastic bag without wrapping
| Study group | Role | What they receive |
|---|---|---|
| Drying before wrapping | Experimental | Immediately after birth, the infant's body will be dried before wrapping in a plastic bag Receives: Other: Drying before wrapping |
| No drying before wrapping | Active comparator | Immediately after birth, the infant will be wrapped in a plastic bag without drying Receives: Other: No drying before wrapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (percentage) of neonates in the normal thermal range (temperature 36.5-37.5°C) at Neonatal Intensive Care Unit admission.
Measured: 25 minutes
Secondary outcomes (9)
Number (percentage) of neonates with hypothermia (temperature <36.5°C) at neonatal intensive care unit admission
Measured: 25 minutes
Number (percentage) of neonates with moderate-severe hypothermia (temperature <36.0°C) at neonatal intensive care unit admission
Measured: 25 minutes
Number (percentage) of neonates hyperthermia (temperature >37.5°C) at NICU admission at neonatal intensive care unit admission
Measured: 25 minutes
Temperature at 1 hour after neonatal intensive care unit admission
Axillary temperature will be registered at 1 hour after neonatal intensive care unit admission
Measured: 60 minutes
Number (percentage) of infants with intraventricular hemorrhage (all grades and grade III-IV)
The grade of intraventricular hemorrhage will be defined on Levine classification
Measured: 10 days
Number (percentage) of infants with respiratory distress syndrome
Respiratory distress syndrome will be defined as presence of clinical signs of respiratory distress and radiological findings
Measured: 72 hours
Number (percentage) of infants with late-onset sepsis
Sespsis will be defined based on the presence of a positive blood colture 72 hours after birth
Measured: 7 days
Number (percentage) of infants with bronchopulmonary dysplasia
Bronchopulmonary dysplasia will be defined as the need for oxygen at 36 postnatal weeks gestation
Measured: 36 postnatal weeks
Number (percentage) of infants died before hospital discharge
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temperature Regulation; Disorder, Fetus or NewbornStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740072
- Sponsor's protocol ID
- NEOUNIPD2(2023)
- Acronym
- NEODRY
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with other researchers upon motivated request
Publications
Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24.
PubMed 23369256Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres JW, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Resuscitation. 2020 Nov;156:A156-A187. doi: 10.1016/j.resuscitation.2020.09.015. Epub 2020 Oct 21.
PubMed 33098917Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
PubMed 33773829Trevisanuto D, Testoni D, de Almeida MFB. Maintaining normothermia: Why and how? Semin Fetal Neonatal Med. 2018 Oct;23(5):333-339. doi: 10.1016/j.siny.2018.03.009. Epub 2018 Mar 21.
PubMed 29599071Cavallin F, Doglioni N, Allodi A, Battajon N, Vedovato S, Capasso L, Gitto E, Laforgia N, Paviotti G, Capretti MG, Gizzi C, Villani PE, Biban P, Pratesi S, Lista G, Ciralli F, Soffiati M, Staffler A, Baraldi E, Trevisanuto D; Servo COntrol for PReterm Infants (SCOPRI) Trial Group. Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):572-577. doi: 10.1136/archdischild-2020-320567. Epub 2021 Feb 17.
PubMed 33597230Cavallin F, Doglioni N, Risso FM, Monari CB, Aversa S, Troiani S, Battajon N, Moschella S, Villani PE, Vedovato S, Maiorca D, Frezza S, Lista G, Laforgia N, Mondello I, Sibona I, Staffler A, Pratesi S, Paviotti G, De Bernardo G, Lama S, Miselli F, Bua J, Gitto E, Pesce S, Baraldi E, Trevisanuto D; NEODRY Trial Group. Drying Very Preterm Infants Before Plastic Wrapping at Birth: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e2556902. doi: 10.1001/jamanetworkopen.2025.56902.
PubMed 41774445
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05740072
- Acronym / sponsor ID
- NEODRY / NEOUNIPD2(2023)
- Keywords
- Newborn, Prematurity, Temperature, Delivery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 22 Feb 2023 (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 is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.
Detailed description
Background: Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge.
A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. While drying is recommended for the thermal management of infants with gestational age >32 weeks, this procedure is not indicated for very preterm infants who should be put in a plastic wrap immediately at birth without drying. However, such indication is based on studies comparing wrapping without drying vs. drying without wrapping, while the potential advantages of combining these interventions were not explored. We hypothesized that drying before wrapping could prevent heat loss immediately after birth and reduce hypothermia at NICU admission in very preterm infants.
Objective: The aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.
Methods: This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. After obtaining parental consent, all infants with estimated birth weight <1500 g and/or gestational age ≤30+6 weeks will be assigned to be managed with or without drying before plastic wrapping. Room temperature and maternal temperature will be measured at the time of delivery. Patients allocated in both groups will be managed based on the current guidelines for neonatal resuscitation. The primary outcome measure will be the proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. Secondary outcome measures will be: proportion of neonates with hypothermia (<36.5°C and <36.0°C) at NICU admission; proportion of hyperthermic neonates (temperature >37.5°C) at NICU admission; temperature at 1 hour after NICU admission; proportion of intraventricular hemorrhage; proportion of respiratory distress syndrome; proportion of late onset sepsis; proportion of bronchopulmonary dysplasia; mortality before hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drying before wrapping | Experimental | Other: Drying before wrappingImmediately after birth, the infant's body will be dried before wrapping in a plastic bag |
| No drying before wrapping | Active comparator | Other: No drying before wrappingImmediately after birth, the infant will be wrapped in a plastic bag without drying |
Who may qualify
- Ages
- 0 minutes to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Estimated birth weight <1500 g and/or gestational age ≤30+6 weeks (and)
- Inborn (and)
- Parental consent; written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian at the maternal admission to the Obstetric Department.
Key exclusion criteria (3 listed)
- Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
- Outborn;
- Parental refusal to participate in the study.
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 |
|---|---|---|
| Drying before wrappingImmediately after birth, the infant's body will be dried before wrapping in a plastic bag | Other | Drying before wrapping |
| No drying before wrappingImmediately after birth, the infant will be put in a plastic bag without wrapping | Other | No drying before wrapping |
Primary outcome
Number (percentage) of neonates in the normal thermal range (temperature 36.5-37.5°C) at Neonatal Intensive Care Unit admission.
Time frame: 25 minutes
9 secondary outcomes
Number (percentage) of neonates with hypothermia (temperature <36.5°C) at neonatal intensive care unit admission
Time frame: 25 minutes
Number (percentage) of neonates with moderate-severe hypothermia (temperature <36.0°C) at neonatal intensive care unit admission
Time frame: 25 minutes
Number (percentage) of neonates hyperthermia (temperature >37.5°C) at NICU admission at neonatal intensive care unit admission
Time frame: 25 minutes
Temperature at 1 hour after neonatal intensive care unit admission
Time frame: 60 minutes
Number (percentage) of infants with intraventricular hemorrhage (all grades and grade III-IV)
Time frame: 10 days
Number (percentage) of infants with respiratory distress syndrome
Time frame: 72 hours
Number (percentage) of infants with late-onset sepsis
Time frame: 7 days
Number (percentage) of infants with bronchopulmonary dysplasia
Time frame: 36 postnatal weeks
Number (percentage) of infants died before hospital discharge
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 23369256Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24.
- Background: PubMed 33098917Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres JW, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Resuscitation. 2020 Nov;156:A156-A187. doi: 10.1016/j.resuscitation.2020.09.015. Epub 2020 Oct 21.
- Background: PubMed 33773829Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
- Background: PubMed 29599071Trevisanuto D, Testoni D, de Almeida MFB. Maintaining normothermia: Why and how? Semin Fetal Neonatal Med. 2018 Oct;23(5):333-339. doi: 10.1016/j.siny.2018.03.009. Epub 2018 Mar 21.
- Background: PubMed 33597230Cavallin F, Doglioni N, Allodi A, Battajon N, Vedovato S, Capasso L, Gitto E, Laforgia N, Paviotti G, Capretti MG, Gizzi C, Villani PE, Biban P, Pratesi S, Lista G, Ciralli F, Soffiati M, Staffler A, Baraldi E, Trevisanuto D; Servo COntrol for PReterm Infants (SCOPRI) Trial Group. Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):572-577. doi: 10.1136/archdischild-2020-320567. Epub 2021 Feb 17.
- Derived from this study: PubMed 41774445Cavallin F, Doglioni N, Risso FM, Monari CB, Aversa S, Troiani S, Battajon N, Moschella S, Villani PE, Vedovato S, Maiorca D, Frezza S, Lista G, Laforgia N, Mondello I, Sibona I, Staffler A, Pratesi S, Paviotti G, De Bernardo G, Lama S, Miselli F, Bua J, Gitto E, Pesce S, Baraldi E, Trevisanuto D; NEODRY Trial Group. Drying Very Preterm Infants Before Plastic Wrapping at Birth: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e2556902. doi: 10.1001/jamanetworkopen.2025.56902.
- Individual participant dataSharing planned: No. Data will be shared with other researchers upon motivated request
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 Drying before wrapping and No drying before wrapping in people with Temperature Regulation; Disorder, Fetus or Newborn, run by University Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. 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.
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?
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?
Number (percentage) of neonates in the normal thermal range (temperature 36.5-37.5°C) at Neonatal Intensive Care Unit admission. (time frame: 25 minutes). 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 NCT05740072, which also lists 6 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 22 Feb 2023.