Hypothermia, Infant, Newborn, Premature
Conditions
Keywords
cord clamping, hypothermia, hyperthermia, polyethylene bag
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.
Interventions
OTHERPolyethylene bag before the umbilical cord is clamped
11 x 16 (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)
Sponsors
University College Dublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In the delivery room, the infant is randomised to application of a polyethylene bag before or after cord clamping. Neither the delivery room care provider nor the investigator are blinded to the group assignment. When the infant is stable, they are be transferred from the delivery room to the neonatal unit. The outcome assessor is the admitting nurse in the neonatal unit who will be blinded to the group assignment.
Intervention model description
Single-centre randomised controlled trail
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 5 minute Apgar | Within 2 hours of birth | Scale (0-10) |
| External cardiac massage in the delivery room | Within 2 hours of birth | Yes/ No, Duration |
| 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. |
| 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. |
| 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. |
| Central catheter placement in first 24 hours | Between 0-24 hours of life | Yes/no. Type and location of catheter |
| Intubation and mechanical ventilation | Term corrected gestation age or hospital discharge (<17 weeks) | Yes/no, type and duration |
| Respiratory Distress Syndrome | Between 0-24 hours of life | Yes/no |
| Non-invasive ventilation (NIV) on the first day of life (24 hours) | Between 0-24 hours of life | Yes/ no, type of NIV |
| Surfactant administration | Day 1 - 7 of life | Yes/ no, route of administration |
| Respiratory support in the DR | Within 2 hours of birth | Type and duration of respiratory support in the DR |
| Pulmonary haemorrhage | Term corrected gestation age or hospital discharge (<17 weeks) | Yes/ no |
| Hypotension requiring inotropes | Term corrected gestation age or hospital discharge (<17 weeks) | Yes/ no, inotropes, duration |
| Intraventricular haemorrhage | Term corrected gestation age or hospital discharge (<17 weeks) | Papile classification |
| Periventricular leukomalacia | 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 |
| 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 |
| Retinopathy of prematurity requiring treatment | Term corrected gestation age or hospital discharge (<17 weeks) | Yes/ no, treatment |
| Oxygen requirement at 36 weeks corrected gestational age | 36 weeks corrected gestational age | Yes/ no |
| Death before discharge from hospital | Term corrected gestation age or hospital discharge (<17 weeks) | Yes/ no |
| Pneumothorax requiring drainage | Term corrected gestation age or hospital discharge (<17 weeks) | Yes/ no, needle aspiration or definitive chest drain or both |
Countries
Ireland
Contacts
Primary ContactLisa K McCarthy, MB BCh BAO
Backup ContactEmma A Dunne, MB BCh BAO
Outcome results
None listed