NewbornNCT04463511
Placing Preterm Infants in Polyethylene Bags Immediately After Birth
A study testing Polyethylene bag before the umbilical cord is clamped in people with Newborn and Infant, run by University College Dublin at 1 site in Ireland.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Newborn, Infant, Hypothermia
- What is being tested?
- Polyethylene bag before the umbilical cord is clamped
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteIreland
- Study dates
- 13 Jul 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
National Maternity Hospital
Dublin, Dubiln, 2
Lisa K McCarthy, MB BCh BAO PhD, 016373100, lmccarthy@nmh.ie
About this study
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).
Read the 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.
- Conditions
- Newborn, Infant, Hypothermia, Premature
- Being tested
- Polyethylene bag before the umbilical cord is clamped
- Keywords
- cord clamping, hypothermia, hyperthermia, polyethylene bag
- Medical subject headings
- Hypothermia, Premature Birth, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene bag before the umbilical cord is clampedOther
11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Polyethylene bag before the umbilical cord is clamped |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 outcomes (22)
Respiratory support in the DR
Type and duration of respiratory support in the DR
Measured: Within 2 hours of birth
5 minute Apgar
Scale (0-10)
Measured: Within 2 hours of birth
External cardiac massage in the delivery room
Yes/ No, Duration
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Between 0-2 hours of life
Central catheter placement in first 24 hours
Yes/no. Type and location of catheter
Measured: Between 0-24 hours of life
Intubation and mechanical ventilation
Yes/no, type and duration
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Respiratory Distress Syndrome
Yes/no
Measured: Between 0-24 hours of life
Non-invasive ventilation (NIV) on the first day of life (24 hours)
Yes/ no, type of NIV
Measured: Between 0-24 hours of life
Surfactant administration
Yes/ no, route of administration
Measured: Day 1 - 7 of life
Pneumothorax requiring drainage
Yes/ no, needle aspiration or definitive chest drain or both
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Pulmonary haemorrhage
Yes/ no
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Hypotension requiring inotropes
Yes/ no, inotropes, duration
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Intraventricular haemorrhage
Papile classification
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Periventricular leukomalacia
Yes/ no
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Necrotising enterocolitis
Bell's staging criteria
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Sepsis - early onset
Yes/ no
Measured: Between 0-72 hours of life
Sepsis - late onset
Yes/ no
Measured: After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks)
Retinopathy of prematurity requiring treatment
Yes/ no, treatment
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Oxygen requirement at 36 weeks corrected gestational age
Yes/ no
Measured: 36 weeks corrected gestational age
Death before discharge from hospital
Yes/ no
Measured: Term corrected gestation age or hospital discharge (<17 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start13 Jul 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre randomised controlled trail
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa K McCarthy, MB BCh BAO, Principal investigator, National Maternity Hospital / University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463511
- Sponsor's protocol ID
- APOLLO_PB_BCC
- Status last verified
- May 2022
- First submitted
- 3 Jul 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29431872Laptook 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.
PubMed 17296783Dunne 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.
PubMed 38212105
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placing Preterm Infants in Polyethylene Bags Immediately After Birth
- ClinicalTrials.gov ID
- NCT04463511
- Acronym / sponsor ID
- APOLLO_PB_BCC
- Conditions
- Newborn, Infant, Hypothermia, Premature
- Keywords
- cord clamping, hypothermia, hyperthermia, polyethylene bag
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre randomised controlled trail
| Arm | Type | Receives |
|---|---|---|
| PB BCC: Polyethylene Bag Before Cord Clamping | Experimental | Other: Polyethylene bag before the umbilical cord is clampedImmediately 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. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene bag before the umbilical cord is clamped11" x 16" (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK) | Other | PB BCC: Polyethylene Bag Before Cord Clamping |
Primary outcome
Temperature on admission to the Neonatal Intensive Care Unit (NICU)
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)
Rectal temperature recorded upon arrival to the NICU, while the infant is in the transport incubator. (measured in degrees celsius)
22 secondary outcomes
Respiratory support in the DR
Time frame: Within 2 hours of birth
5 minute Apgar
Time frame: Within 2 hours of birth
External cardiac massage in the delivery room
Time frame: Within 2 hours of birth
Infant temperature recordings in the delivery room
Time frame: Within 2 hours of birth
Axillary temperature on admission to the NICU
Time frame: Between 0-2 hours of life
Temperature 1 hour after admission
Time frame: Between 0-2 hours of life
Central catheter placement in first 24 hours
Time frame: Between 0-24 hours of life
Intubation and mechanical ventilation
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Respiratory Distress Syndrome
Time frame: Between 0-24 hours of life
Non-invasive ventilation (NIV) on the first day of life (24 hours)
Time frame: Between 0-24 hours of life
Surfactant administration
Time frame: Day 1 - 7 of life
Pneumothorax requiring drainage
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Pulmonary haemorrhage
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Hypotension requiring inotropes
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Intraventricular haemorrhage
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Periventricular leukomalacia
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Necrotising enterocolitis
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Sepsis - early onset
Time frame: Between 0-72 hours of life
Sepsis - late onset
Time frame: After 72 hours of life until term corrected or hospital discharge (maximum 16 weeks)
Retinopathy of prematurity requiring treatment
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Oxygen requirement at 36 weeks corrected gestational age
Time frame: 36 weeks corrected gestational age
Death before discharge from hospital
Time frame: Term corrected gestation age or hospital discharge (<17 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Results publication: PubMed 29431872McCall 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 publication: PubMed 17296783Laptook 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.
- Derived from this study: PubMed 38212105Dunne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa K McCarthy, MB BCh BAO principal investigator
National Maternity Hospital / University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene bag before the umbilical cord is clamped in people with Newborn and Infant, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa K McCarthy, MB BCh BAO (+3531637310 ext. 3410, lmccarthy@nmh.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature on admission to the Neonatal Intensive Care Unit (NICU) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463511, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.