Placing Preterm Infants in Polyethylene Bags Immediately After Birth

Hypothermia Clinical Trial

Official title:

Placing Preterm Infants in Polyethylene Bags Immediately After Birth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463511
• Other study ID #: APOLLO_PB_BCC
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2022
• Source: University College Dublin
• Contact: Lisa K McCarthy, MB BCh BAO
• Phone: +3531637310
• Email: lmccarthy[@]nmh.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: January 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Infant
• Newborn
• Premature

Intervention

Other:
• Polyethylene bag before the umbilical cord is clamped
11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)

Locations

Country	Name	City	State
Ireland	National Maternity Hospital	Dublin	Dubiln

Sponsors (1)

Lead Sponsor	Collaborator
University College Dublin

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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. Epub 2007 Feb 12. — View Citation

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:CD004210. doi: 10.1002/14651858.CD004210.pub5. Review. — View Citation

Outcome

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