Placing Preterm Infants in Polyethylene Bags Immediately After Birth
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PB BCC: Polyethylene Bag Before Cord Clamping 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. |
Other: Polyethylene bag before the umbilical cord is clamped
11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)
|
| No Intervention: PB ACC: Polyethylene Bag After Cord Clamping Infants will not be placed in a PB immediately after birth. After the cord has been clamped and cut, the infant will be transferred to the resuscitaire where they will be placed in a PB. |
Outcome Measures
Primary Outcome Measures
- 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
- Respiratory support in the DR [Within 2 hours of birth]
Type and duration of respiratory support in the DR
- 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
- Pneumothorax requiring drainage [Term corrected gestation age or hospital discharge (<17 weeks)]
Yes/ no, needle aspiration or definitive chest drain or both
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Maternity Hospital | Dublin | Dubiln | Ireland | 2 |
Sponsors and Collaborators
- University College Dublin
Investigators
- Principal Investigator: Lisa K McCarthy, MB BCh BAO, National Maternity Hospital / University College Dublin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APOLLO_PB_BCC