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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
194
11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)
National Maternity Hospital
Dublin, Dubiln, Ireland
RECRUITINGTemperature 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)
Time frame: The primary outcome measure will be determined on admission to the NICU, before the infant is removed from the transport incubator (< 90minutes of life)
Respiratory support in the DR
Type and duration of respiratory support in the DR
Time frame: Within 2 hours of birth
5 minute Apgar
Scale (0-10)
Time frame: Within 2 hours of birth
External cardiac massage in the delivery room
Yes/ No, Duration
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Between 0-2 hours of life
Central catheter placement in first 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yes/no. Type and location of catheter
Time frame: Between 0-24 hours of life
Intubation and mechanical ventilation
Yes/no, type and duration
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Respiratory Distress Syndrome
Yes/no
Time frame: Between 0-24 hours of life
Non-invasive ventilation (NIV) on the first day of life (24 hours)
Yes/ no, type of NIV
Time frame: Between 0-24 hours of life
Surfactant administration
Yes/ no, route of administration
Time frame: Day 1 - 7 of life
Pneumothorax requiring drainage
Yes/ no, needle aspiration or definitive chest drain or both
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Pulmonary haemorrhage
Yes/ no
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Hypotension requiring inotropes
Yes/ no, inotropes, duration
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Intraventricular haemorrhage
Papile classification
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Periventricular leukomalacia
Yes/ no
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Necrotising enterocolitis
Bell's staging criteria
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Sepsis - early onset
Yes/ no
Time frame: Between 0-72 hours of life
Sepsis - late onset
Yes/ no
Time frame: After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks)
Retinopathy of prematurity requiring treatment
Yes/ no, treatment
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Oxygen requirement at 36 weeks corrected gestational age
Yes/ no
Time frame: 36 weeks corrected gestational age
Death before discharge from hospital
Yes/ no
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)