Placing Preterm Infants in Polyethylene Bags Immediately After Birth
- Conditions
- InfantPrematureNewbornHypothermia
- Interventions
- Other: Polyethylene bag before the umbilical cord is clamped
- Registration Number
- NCT04463511
- Lead Sponsor
- University College Dublin
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 194
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PB BCC: Polyethylene Bag Before Cord Clamping Polyethylene bag before the umbilical cord is clamped 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.
- Primary Outcome Measures
Name Time Method Temperature on admission to the Neonatal Intensive Care Unit (NICU) The primary outcome measure will be determined on admission to the NICU, before the infant is removed from the transport incubator (< 90minutes of life) Rectal temperature recorded upon arrival to the NICU, while the infant is in the transport incubator. (measured in degrees celsius)
- Secondary Outcome Measures
Name Time Method External cardiac massage in the delivery room Within 2 hours of birth Yes/ No, Duration
Hypotension requiring inotropes Term corrected gestation age or hospital discharge (<17 weeks) Yes/ no, inotropes, duration
Respiratory support in the DR Within 2 hours of birth Type and duration of respiratory support in the DR
Axillary temperature on admission to the NICU Between 0-2 hours of life Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Intubation and mechanical ventilation Term corrected gestation age or hospital discharge (<17 weeks) Yes/no, type and duration
Pulmonary haemorrhage Term corrected gestation age or hospital discharge (<17 weeks) Yes/ no
Necrotising enterocolitis Term corrected gestation age or hospital discharge (<17 weeks) Bell's staging criteria
Death before discharge from hospital Term corrected gestation age or hospital discharge (<17 weeks) Yes/ no
5 minute Apgar Within 2 hours of birth Scale (0-10)
Infant temperature recordings in the delivery room Within 2 hours of birth Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Central catheter placement in first 24 hours Between 0-24 hours of life Yes/no. Type and location of catheter
Surfactant administration Day 1 - 7 of life Yes/ no, route of administration
Intraventricular haemorrhage Term corrected gestation age or hospital discharge (<17 weeks) Papile classification
Respiratory Distress Syndrome Between 0-24 hours of life Yes/no
Pneumothorax requiring drainage Term corrected gestation age or hospital discharge (<17 weeks) Yes/ no, needle aspiration or definitive chest drain or both
Retinopathy of prematurity requiring treatment Term corrected gestation age or hospital discharge (<17 weeks) Yes/ no, treatment
Temperature 1 hour after admission Between 0-2 hours of life Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Non-invasive ventilation (NIV) on the first day of life (24 hours) Between 0-24 hours of life Yes/ no, type of NIV
Sepsis - early onset Between 0-72 hours of life Yes/ no
Sepsis - late onset After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks) Yes/ no
Periventricular leukomalacia Term corrected gestation age or hospital discharge (<17 weeks) Yes/ no
Oxygen requirement at 36 weeks corrected gestational age 36 weeks corrected gestational age Yes/ no
Trial Locations
- Locations (1)
National Maternity Hospital
🇮🇪Dublin, Dubiln, Ireland