Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth

NCT05740072 | Unknown

• 1 other identifier: NEOUNIPD2(2023)
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief 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 birth in very preterm infants.

Conditions

Temperature Regulation; Disorder, Fetus or Newborn

Keywords

Newborn; Prematurity; Temperature; Delivery

Outcome Measures

Primary Outcomes (1)

• Number (percentage) of neonates in the normal thermal range (temperature 36.5-37.5°C) at Neonatal Intensive Care Unit admission.

  25 minutes

Secondary Outcomes (9)

• Number (percentage) of neonates with hypothermia (temperature <36.5°C) at neonatal intensive care unit admission

  25 minutes

• Number (percentage) of neonates with moderate-severe hypothermia (temperature <36.0°C) at neonatal intensive care unit admission

  25 minutes

• Number (percentage) of neonates hyperthermia (temperature >37.5°C) at NICU admission at neonatal intensive care unit admission

  25 minutes

• Temperature at 1 hour after neonatal intensive care unit admission

  60 minutes

• Number (percentage) of infants with intraventricular hemorrhage (all grades and grade III-IV)

  10 days

Study Arms (2)

Drying before wrapping

EXPERIMENTAL

Immediately after birth, the infant's body will be dried before wrapping in a plastic bag

Other: Drying before wrapping

No drying before wrapping

ACTIVE COMPARATOR

Immediately after birth, the infant will be wrapped in a plastic bag without drying

Other: No drying before wrapping

Interventions

Drying before wrapping OTHER

Immediately after birth, the infant's body will be dried before wrapping in a plastic bag

Drying before wrapping

No drying before wrapping OTHER

Immediately after birth, the infant will be put in a plastic bag without wrapping

No drying before wrapping

Eligibility Criteria

• Age: 0 Minutes - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
• Outborn;
• Parental refusal to participate in the study.

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (1)

Azienda Ospedaliera di Padova, University of Padova

Padua, 35128, Italy

Location

Related Publications (5)

• 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.

  PMID: 23369256 BACKGROUND

• Wyckoff 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.

  PMID: 33098917 BACKGROUND

• Madar 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.

  PMID: 33773829 BACKGROUND

• Trevisanuto 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.

  PMID: 29599071 BACKGROUND

• Cavallin 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.

  PMID: 33597230 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 22, 2023
• Study Start: February 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)