Placing Preterm Infants in Polyethylene Bags Immediately After Birth

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).

Study Overview

• Status: Recruiting
• Conditions: Hypothermia; Infant; Newborn; Premature
• Intervention / Treatment: Other: Polyethylene bag before the umbilical cord is clamped

Detailed Description

Newly born preterm infants that develop abnormal temperature after birth have higher morbidity and mortality. Placing infants < 32 weeks' gestation in a polyethylene bag (PB) in the delivery room (DR) reduces the rate of hypothermia on admission to the Neonatal Intensive Care Unit (NICU). Since 2012, the rate of admission hypothermia in preterm infants, placed in a PB in the DR at the National Maternity Hospital (NMH), has increased significantly. This may be as a result of heat loss while the infant remains attached to the cord.

Our primary objective is to determine if placing preterm infants in a 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 NICU.

• Study Type: Interventional
• Enrollment (Anticipated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa K McCarthy, MB BCh BAO; Phone Number: 3410 +3531637310; Email: lmccarthy@nmh.ie
• Study Contact Backup: Name: Emma A Dunne, MB BCh BAO; Phone Number: 3410 +35316373100; Email: emma.dunne9@gmail.com

Study Locations

• Ireland
  • Dubiln
    • Dublin, Dubiln, Ireland, 2
      • Recruiting
      • National Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PB BCC: Polyethylene Bag Before Cord Clamping; 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; 11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)
No Intervention: PB ACC: Polyethylene Bag After Cord Clamping; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory support in the DR	Type and duration of respiratory support in the DR	Within 2 hours of birth
5 minute Apgar	Scale (0-10)	Within 2 hours of birth
External cardiac massage in the delivery room	Yes/ No, Duration	Within 2 hours of birth
Infant temperature recordings in the delivery room	Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.	Within 2 hours of birth
Axillary temperature on admission to the NICU	Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.	Between 0-2 hours of life
Temperature 1 hour after admission	Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.	Between 0-2 hours of life
Central catheter placement in first 24 hours	Yes/no. Type and location of catheter	Between 0-24 hours of life
Intubation and mechanical ventilation	Yes/no, type and duration	Term corrected gestation age or hospital discharge (<17 weeks)
Respiratory Distress Syndrome	Yes/no	Between 0-24 hours of life
Non-invasive ventilation (NIV) on the first day of life (24 hours)	Yes/ no, type of NIV	Between 0-24 hours of life
Surfactant administration	Yes/ no, route of administration	Day 1 - 7 of life
Pneumothorax requiring drainage	Yes/ no, needle aspiration or definitive chest drain or both	Term corrected gestation age or hospital discharge (<17 weeks)
Pulmonary haemorrhage	Yes/ no	Term corrected gestation age or hospital discharge (<17 weeks)
Hypotension requiring inotropes	Yes/ no, inotropes, duration	Term corrected gestation age or hospital discharge (<17 weeks)
Intraventricular haemorrhage	Papile classification	Term corrected gestation age or hospital discharge (<17 weeks)
Periventricular leukomalacia	Yes/ no	Term corrected gestation age or hospital discharge (<17 weeks)
Necrotising enterocolitis	Bell's staging criteria	Term corrected gestation age or hospital discharge (<17 weeks)
Sepsis - early onset	Yes/ no	Between 0-72 hours of life
Sepsis - late onset	Yes/ no	After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks)
Retinopathy of prematurity requiring treatment	Yes/ no, treatment	Term corrected gestation age or hospital discharge (<17 weeks)
Oxygen requirement at 36 weeks corrected gestational age	Yes/ no	36 weeks corrected gestational age
Death before discharge from hospital	Yes/ no	Term corrected gestation age or hospital discharge (<17 weeks)

Collaborators and Investigators

• Sponsor: University College Dublin
• Investigators: Principal Investigator: Lisa K McCarthy, MB BCh BAO, National Maternity Hospital / University College Dublin

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: hyperthermia; hypothermia; cord clamping; polyethylene bag
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: APOLLO_PB_BCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No