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Placing Preterm Infants in Polyethylene Bags Immediately After Birth

Primary Purpose

Newborn, Infant, Hypothermia

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Polyethylene bag before the umbilical cord is clamped
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Newborn focused on measuring cord clamping, hypothermia, hyperthermia, polyethylene bag

Eligibility Criteria

undefined - 32 Weeks (Child)All SexesAccepts 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

Sites / Locations

  • National Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PB BCC: Polyethylene Bag Before Cord Clamping

PB ACC: Polyethylene Bag After Cord Clamping

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Respiratory support in the DR
Type and duration of respiratory support in the DR
5 minute Apgar
Scale (0-10)
External cardiac massage in the delivery room
Yes/ No, Duration
Infant temperature recordings in the delivery room
Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Axillary temperature on admission to the NICU
Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Temperature 1 hour after admission
Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Central catheter placement in first 24 hours
Yes/no. Type and location of catheter
Intubation and mechanical ventilation
Yes/no, type and duration
Respiratory Distress Syndrome
Yes/no
Non-invasive ventilation (NIV) on the first day of life (24 hours)
Yes/ no, type of NIV
Surfactant administration
Yes/ no, route of administration
Pneumothorax requiring drainage
Yes/ no, needle aspiration or definitive chest drain or both
Pulmonary haemorrhage
Yes/ no
Hypotension requiring inotropes
Yes/ no, inotropes, duration
Intraventricular haemorrhage
Papile classification
Periventricular leukomalacia
Yes/ no
Necrotising enterocolitis
Bell's staging criteria
Sepsis - early onset
Yes/ no
Sepsis - late onset
Yes/ no
Retinopathy of prematurity requiring treatment
Yes/ no, treatment
Oxygen requirement at 36 weeks corrected gestational age
Yes/ no
Death before discharge from hospital
Yes/ no

Full Information

First Posted
July 3, 2020
Last Updated
May 17, 2022
Sponsor
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT04463511
Brief Title
Placing Preterm Infants in Polyethylene Bags Immediately After Birth
Official Title
Placing Preterm Infants in Polyethylene Bags Immediately After Birth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College Dublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn, Infant, Hypothermia, Premature
Keywords
cord clamping, hypothermia, hyperthermia, polyethylene bag

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-centre randomised controlled trail
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PB BCC: Polyethylene Bag Before Cord Clamping
Arm Type
Experimental
Arm 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.
Arm Title
PB ACC: Polyethylene Bag After Cord Clamping
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Polyethylene bag before the umbilical cord is clamped
Intervention Description
11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)
Primary Outcome Measure Information:
Title
Temperature on admission to the Neonatal Intensive Care Unit (NICU)
Description
Rectal temperature recorded upon arrival to the NICU, while the infant is in the transport incubator. (measured in degrees celsius)
Time Frame
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 Measure Information:
Title
Respiratory support in the DR
Description
Type and duration of respiratory support in the DR
Time Frame
Within 2 hours of birth
Title
5 minute Apgar
Description
Scale (0-10)
Time Frame
Within 2 hours of birth
Title
External cardiac massage in the delivery room
Description
Yes/ No, Duration
Time Frame
Within 2 hours of birth
Title
Infant temperature recordings in the delivery room
Description
Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Time Frame
Within 2 hours of birth
Title
Axillary temperature on admission to the NICU
Description
Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Time Frame
Between 0-2 hours of life
Title
Temperature 1 hour after admission
Description
Measured with Microlife MT 1931 digital thermometer at the rectum. Recorded in degrees celsius.
Time Frame
Between 0-2 hours of life
Title
Central catheter placement in first 24 hours
Description
Yes/no. Type and location of catheter
Time Frame
Between 0-24 hours of life
Title
Intubation and mechanical ventilation
Description
Yes/no, type and duration
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)
Title
Respiratory Distress Syndrome
Description
Yes/no
Time Frame
Between 0-24 hours of life
Title
Non-invasive ventilation (NIV) on the first day of life (24 hours)
Description
Yes/ no, type of NIV
Time Frame
Between 0-24 hours of life
Title
Surfactant administration
Description
Yes/ no, route of administration
Time Frame
Day 1 - 7 of life
Title
Pneumothorax requiring drainage
Description
Yes/ no, needle aspiration or definitive chest drain or both
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)
Title
Pulmonary haemorrhage
Description
Yes/ no
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)
Title
Hypotension requiring inotropes
Description
Yes/ no, inotropes, duration
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)
Title
Intraventricular haemorrhage
Description
Papile classification
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)
Title
Periventricular leukomalacia
Description
Yes/ no
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)
Title
Necrotising enterocolitis
Description
Bell's staging criteria
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)
Title
Sepsis - early onset
Description
Yes/ no
Time Frame
Between 0-72 hours of life
Title
Sepsis - late onset
Description
Yes/ no
Time Frame
After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks)
Title
Retinopathy of prematurity requiring treatment
Description
Yes/ no, treatment
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)
Title
Oxygen requirement at 36 weeks corrected gestational age
Description
Yes/ no
Time Frame
36 weeks corrected gestational age
Title
Death before discharge from hospital
Description
Yes/ no
Time Frame
Term corrected gestation age or hospital discharge (<17 weeks)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa K McCarthy, MB BCh BAO
Phone
+3531637310
Ext
3410
Email
lmccarthy@nmh.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Emma A Dunne, MB BCh BAO
Phone
+35316373100
Ext
3410
Email
emma.dunne9@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa K McCarthy, MB BCh BAO
Organizational Affiliation
National Maternity Hospital / University College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Maternity Hospital
City
Dublin
State/Province
Dubiln
ZIP/Postal Code
2
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa K McCarthy, MB BCh BAO PhD
Phone
016373100
Email
lmccarthy@nmh.ie

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29431872
Citation
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.
Results Reference
result
PubMed Identifier
17296783
Citation
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.
Results Reference
result

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Placing Preterm Infants in Polyethylene Bags Immediately After Birth

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