Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PB BCC: Polyethylene Bag Before Cord Clamping | Experimental | 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. |
|
| PB ACC: Polyethylene Bag After Cord Clamping | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene bag before the umbilical cord is clamped | Other | 11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Temperature 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) | The primary outcome measure will be determined on admission to the NICU, before the infant is removed from the transport incubator (< 90minutes of life) |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory support in the DR | Type and duration of respiratory support in the DR | Within 2 hours of birth |
| 5 minute Apgar | Scale (0-10) |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa K McCarthy, MB BCh BAO | Contact | +3531637310 | 3410 | lmccarthy@nmh.ie |
| Emma A Dunne, MB BCh BAO | Contact | +35316373100 | 3410 | emma.dunne9@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lisa K McCarthy, MB BCh BAO | National Maternity Hospital / University College Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Maternity Hospital | Recruiting | Dublin | Dubiln | 2 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29431872 | Result | 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. | |
| 17296783 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| D047928 | Premature Birth |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
Not provided
Not provided
Single-centre randomised controlled trail
Not provided
Not provided
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.
| Within 2 hours of birth |
| External cardiac massage in the delivery room | Yes/ No, Duration | 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. | 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. | 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. | Between 0-2 hours of life |
| Central catheter placement in first 24 hours | Yes/no. Type and location of catheter | Between 0-24 hours of life |
| Intubation and mechanical ventilation | Yes/no, type and duration | Term corrected gestation age or hospital discharge (<17 weeks) |
| Respiratory Distress Syndrome | Yes/no | Between 0-24 hours of life |
| Non-invasive ventilation (NIV) on the first day of life (24 hours) | Yes/ no, type of NIV | Between 0-24 hours of life |
| Surfactant administration | Yes/ no, route of administration | Day 1 - 7 of life |
| Pneumothorax requiring drainage | Yes/ no, needle aspiration or definitive chest drain or both | Term corrected gestation age or hospital discharge (<17 weeks) |
| Pulmonary haemorrhage | Yes/ no | Term corrected gestation age or hospital discharge (<17 weeks) |
| Hypotension requiring inotropes | Yes/ no, inotropes, duration | Term corrected gestation age or hospital discharge (<17 weeks) |
| Intraventricular haemorrhage | Papile classification | Term corrected gestation age or hospital discharge (<17 weeks) |
| Periventricular leukomalacia | Yes/ no | Term corrected gestation age or hospital discharge (<17 weeks) |
| Necrotising enterocolitis | Bell's staging criteria | Term corrected gestation age or hospital discharge (<17 weeks) |
| Sepsis - early onset | Yes/ no | Between 0-72 hours of life |
| Sepsis - late onset | Yes/ no | After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks) |
| Retinopathy of prematurity requiring treatment | Yes/ no, treatment | Term corrected gestation age or hospital discharge (<17 weeks) |
| Oxygen requirement at 36 weeks corrected gestational age | Yes/ no | 36 weeks corrected gestational age |
| Death before discharge from hospital | Yes/ no | Term corrected gestation age or hospital discharge (<17 weeks) |
| 38212105 | Derived | Dunne EA, Ni Chathasaigh CM, Geraghty LE, O'Donnell CP, McCarthy LK. Polyethylene bags before cord clamping in very preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2024 Apr 18;109(3):317-321. doi: 10.1136/archdischild-2023-325808. |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |