Placing Preterm Infants in Polyethylene Bags Immediately After Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2023-01-01

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).

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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.

Conditions

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Newborn Infant Hypothermia Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-centre randomised controlled trail

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Polyethylene bag before the umbilical cord is clamped

Intervention Type OTHER

11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Polyethylene bag before the umbilical cord is clamped

11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)

Intervention Type OTHER

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

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes