Placing Preterm Infants in Polyethylene Bags Immediately After Birth

University College Dublin

Status: Unknown

Conditions: Premature; Infant; Newborn; Hypothermia

Treatments: Other: Polyethylene bag before the umbilical cord is clamped

Study type: Interventional

Funder types: Other

Identifiers

NCT04463511

APOLLO_PB_BCC

Details and patient eligibility

About

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).

Full 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.

Enrollment: 194 estimated patients

Sex: All

Ages: Under 32 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 2 patient groups

PB BCC: Polyethylene Bag Before Cord Clamping

Experimental group

Description:

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.

Treatment:

Other: Polyethylene bag before the umbilical cord is clamped

PB ACC: Polyethylene Bag After Cord Clamping

No Intervention group

Description:

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.