Clinical trial NCT04463511: Placing Preterm Infants in Polyethylene Bags Immediately After Birth
Official title: Placing Preterm Infants in Polyethylene Bags Immediately After Birth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Newborn
Infant
Hypothermia
Premature
Keywords: cord clamping
hypothermia
hyperthermia
polyethylene bag
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 194
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre randomised controlled trail
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Temperature on admission to the Neonatal Intensive Care Unit (NICU)
timeFrame: 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:
measure: Respiratory support in the DR
timeFrame: Within 2 hours of birth
measure: 5 minute Apgar
timeFrame: Within 2 hours of birth
measure: External cardiac massage in the delivery room
timeFrame: Within 2 hours of birth
measure: Infant temperature recordings in the delivery room
timeFrame: Within 2 hours of birth
measure: Axillary temperature on admission to the NICU
timeFrame: Between 0-2 hours of life
measure: Temperature 1 hour after admission
timeFrame: Between 0-2 hours of life
measure: Central catheter placement in first 24 hours
timeFrame: Between 0-24 hours of life
measure: Intubation and mechanical ventilation
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
measure: Respiratory Distress Syndrome
timeFrame: Between 0-24 hours of life
measure: Non-invasive ventilation (NIV) on the first day of life (24 hours)
timeFrame: Between 0-24 hours of life
measure: Surfactant administration
timeFrame: Day 1 - 7 of life
measure: Pneumothorax requiring drainage
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
measure: Pulmonary haemorrhage
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
measure: Hypotension requiring inotropes
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
measure: Intraventricular haemorrhage
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
measure: Periventricular leukomalacia
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
measure: Necrotising enterocolitis
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
measure: Sepsis - early onset
timeFrame: Between 0-72 hours of life
measure: Sepsis - late onset
timeFrame: After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks)
measure: Retinopathy of prematurity requiring treatment
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
measure: Oxygen requirement at 36 weeks corrected gestational age
timeFrame: 36 weeks corrected gestational age
measure: Death before discharge from hospital
timeFrame: Term corrected gestation age or hospital discharge (<17 weeks)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: National Maternity Hospital
state: Dubiln
Study officials:
affiliation: National Maternity Hospital / University College Dublin
name: Lisa K McCarthy, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
References:
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(2):CD004210. doi: 10.1002/14651858.CD004210.pub5.
citation: 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.