Placing Preterm Infants in Polyethylene Bags Immediately After Birth

NCT04463511 | Unknown

• 1 other identifier: APOLLO_PB_BCC
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: To determine if placing preterm infants in a polyethylene bag (PB) immediately after birth, before the umbilical cord is clamped, will increase the number of preterm infants with a normal temperature on admission to the Neonatal Intensive Care Unit (NICU).

Conditions

Newborn; Infant; Hypothermia; Premature

Keywords

cord clamping; hypothermia; hyperthermia; polyethylene bag

Outcome Measures

Primary Outcomes (1)

• Temperature on admission to the Neonatal Intensive Care Unit (NICU)

  Rectal temperature recorded upon arrival to the NICU, while the infant is in the transport incubator. (measured in degrees celsius)

  The primary outcome measure will be determined on admission to the NICU, before the infant is removed from the transport incubator (< 90minutes of life)

Secondary Outcomes (22)

• Respiratory support in the DR

  Within 2 hours of birth

• 5 minute Apgar

  Within 2 hours of birth

• External cardiac massage in the delivery room

  Within 2 hours of birth

• Infant temperature recordings in the delivery room

  Within 2 hours of birth

• Axillary temperature on admission to the NICU

  Between 0-2 hours of life

Study Arms (2)

PB BCC: Polyethylene Bag Before Cord Clamping

EXPERIMENTAL

Immediately after delivery, while still attached to placental circulation, infants will be placed in a PB. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire for ongoing care. In the case of caesarean section a sterile bag will be used and prepared observing sterile techniques. A member of the neonatal team donned in sterile gown and gloves will assist the obstetrician in placing the infant in the PB.

Other: Polyethylene bag before the umbilical cord is clamped

PB ACC: Polyethylene Bag After Cord Clamping

NO INTERVENTION

Infants will not be placed in a PB immediately after birth. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire where they will be placed in a PB.

Interventions

Polyethylene bag before the umbilical cord is clamped OTHER

11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)

PB BCC: Polyethylene Bag Before Cord Clamping

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants who are inborn at the National Maternity Hospital at \< 32 (up to 31+6) weeks' gestation by best obstetric estimate will be included in the study.

You may not qualify if:

• Infants with a large abdominal wall or neural tube defects
• Infants with an imperforate anus
• Infants to whom resuscitative measures are not initiated in the DR

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

National Maternity Hospital

Dublin, Dubiln, 2, Ireland

RECRUITING

Related Publications (3)

• McCall EM, Alderdice F, Halliday HL, Vohra S, Johnston L. Interventions to prevent hypothermia at birth in preterm and/or low birth weight infants. Cochrane Database Syst Rev. 2018 Feb 12;2(2):CD004210. doi: 10.1002/14651858.CD004210.pub5.

  PMID: 29431872 RESULT

• Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.

  PMID: 17296783 RESULT

• Dunne EA, Ni Chathasaigh CM, Geraghty LE, O'Donnell CP, McCarthy LK. Polyethylene bags before cord clamping in very preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2024 Apr 18;109(3):317-321. doi: 10.1136/archdischild-2023-325808.

  PMID: 38212105 DERIVED

MeSH Terms

Conditions

Hypothermia; Premature Birth; Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Lisa K McCarthy, MB BCh BAO

  National Maternity Hospital / University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa K McCarthy, MB BCh BAO

CONTACT

+3531637310; lmccarthy@nmh.ie

Emma A Dunne, MB BCh BAO

CONTACT

+35316373100; emma.dunne9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the delivery room, the infant is randomised to application of a polyethylene bag before or after cord clamping. Neither the delivery room care provider nor the investigator are blinded to the group assignment. When the infant is stable, they are be transferred from the delivery room to the neonatal unit. The outcome assessor is the admitting nurse in the neonatal unit who will be blinded to the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre randomised controlled trail

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 9, 2020
• Study Start: July 13, 2020
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)