Placing Preterm Infants in Polyethylene Bags Immediately After Birth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Placing Preterm Infants in Polyethylene Bags Immediately After Birth

Conditions
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Newborn, Infant, Hypothermia, Premature

Intervention / Treatment
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* Other: Polyethylene bag before the umbilical cord is clamped


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-centre randomised controlled trail
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PB BCC: Polyethylene Bag Before Cord Clamping<br>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<br>* 11 x 16 (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)<br>|
| No Intervention: PB ACC: Polyethylene Bag After Cord Clamping<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cord clamping, hypothermia, hyperthermia, polyethylene bag