Hypothermia, NewbornUPNCT04761484
Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU
A study testing Vascular access on admission in people with Hypothermia, Newborn and Preterm Birth Complication, run by University College Dublin at 1 site in Ireland.
Trial summary
Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. Read more about this study
- Who is it for?
- Ages 1 minute to 60 minutesHealthy volunteers can take part
- Conditions the study is for
- Hypothermia, Newborn, Preterm Birth Complication, Neonatal Hypothermia
- What is being tested?
- Vascular access on admission
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteIreland
- Study dates
- 1 Mar 2021to Oct 2022
- 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 1 minute to 60 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- inborn infants admitted to the NICU with;
- gestational age < 29 weeks (up to 28+6 weeks) OR
- birth weight < 1250g.
Who cannot join
- end of life (palliative) care
- large abdominal wall defects
- imperforate anus.
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
Emma Dunne, 0877799751, emma.dunne9@gmail.com
About this study
Official title: A Randomised Trial of Umbilical or Peripheral Catheter Insertion for Preterm Infants on NICU Admission
Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission.
The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.
Read the detailed description
Hypothermia is an independent risk factor for death in preterm newborns.(1) Despite measures to improve temperature in preterm newborns in the delivery room (DR), hypothermia on admission to the neonatal intensive care unit (NICU) at NMH is common. In a cohort of infants < 32 weeks' gestation born at NMH in 2019, 54% of infants had a rectal temperature < 36.5 oC on admission to the NICU.(2)
Many preterm infants have procedures performed soon after admission to the NICU; in 2019, 98% of infants born before 29 weeks' gestation at NMH had an umbilical venous catheter inserted. This may/often involve(s) prolonged periods of handling and potential exposure to cold.
The investigators prospectively studied a cohort of 26 infants < 32 weeks who had invasive procedures within 3 hours of birth performed in the NICU at NMH between November 2018 and June 2019. Almost three-quarters [19/26 (73%)] had an abnormal temperature at the beginning of the procedure; and 17/26 (65%) had an abnormal temperature at the end of the procedure. Only 3 (11%) infants maintained a normal temperature throughout the procedure. Perhaps more concerning is the severity of the hypothermia observed; 13 (50%) infants had a temperature < 36.0oC before and 11 (42%) after the procedure. The median duration of procedure was 53 (37, 73) minutes.(3)
The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.
- Being tested
- Vascular access on admission
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular access on admissionProcedure or surgery
PIVC insertion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Insertion of peripheral venous catheter on admission to the NICU Receives: Procedure: Vascular access on admission |
| Control | No intervention | Insertion of and umbilical venous catheter on admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core (rectal) temperature 2 hours after birth
Core (rectal) temperature 2 hours after birth
Measured: 2 hours
Secondary outcomes (27)
Axillary temperature at the end of the procedure
Measured: up to 24 hours
Mean difference in axillary temperature from admission to end of procedure
Measured: up to 24 hours
Time to completion of procedure (incubator roof down, portholes closed and hands off)
Measured: up to 24 hours
Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine)
Measured: up to 24 hours
Number (%) infants that have umbilical catheters inserted during their admission
Measured: up to 24 hours
Number (%) lines used without repositioning
Measured: up to 24 hours
Number (%) lines repositioned
Measured: up to 24 hours
Number (%) of low lying umbilical venous catheters
Measured: up to 24 hours
Number (%) of infants' in whom attempted placement of an umbilical line was not successful
Definition: an attempt made to insert a central catheter that is not used at any point during the infant's admission (i.e. nothing was infused through the line)
Measured: up to 24 hours
Number of peripheral line attempts
Measured: up to 24 hours
Number (%) of infants in whom PIVC as first point of access was unsuccessful (nothing was infused through the line)
Measured: 24 hours
Complications of line insertion/placement
Measured: 10 days
Blood stream infections (CRBSI)
Measured: up to 16 weeks
Number of x-rays performed in first 24 hours
Measured: 24 hours
Blood sampling in first 24 hours
Measured: 24 hours
Number of blood tests in 72 hours
Measured: 3 days
Number of blood transfusions during hospital stay
Measured: up to 26 weeks
Peripheral arterial line insertion in the first 7 days of life
Measured: 7 days
PICC line insertion in the first 7 days of life
Measured: 7 days
Inotropes administered in the first 72 hours of life
Measured: 3 days
Intubation + Ventilation
Measured: Up to 3 days
Surfactant administration
Measured: up to 3 days
Necrotizing enterocolitis (Bell's staging)
Measured: Up to 3 months
Intraventricular Haemorrhage (Papile classification)
Measured: Up to 6 months
Periventricular leukomalacia
Measured: Up to 6 months
Chronic lung disease
Measured: Up to 3 months
In hospital mortality
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, 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
- Randomly assigned in blocks of 4 in a 1:1 ratio, stratified by GA (23 - 25+6, 26 - 28+6) and by admission temperature (normal temperature \[36.5oC- 37.5oC\] , abnormal temperature \[\<36.5oC or \>37.5oC\]).
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Research Council
- Responsible party
- Sponsor
- Investigators
- Colm PF O'Donnell, MB BCh BAO, Principal investigator, The National Maternity HospitalLisa K McCarthy, MB BCh BAO, Principal investigator, The National Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761484
- Sponsor's protocol ID
- APOLLO_UP
- Acronym
- UP
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Umbilical or Peripheral Catheter Insertion for Preterm Infants on NICU Admission
- ClinicalTrials.gov ID
- NCT04761484
- Acronym / sponsor ID
- UP / APOLLO_UP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Irish Research Council
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 21 Feb 2021 (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.
Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission.
The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.
Detailed description
Hypothermia is an independent risk factor for death in preterm newborns.(1) Despite measures to improve temperature in preterm newborns in the delivery room (DR), hypothermia on admission to the neonatal intensive care unit (NICU) at NMH is common. In a cohort of infants < 32 weeks' gestation born at NMH in 2019, 54% of infants had a rectal temperature < 36.5 oC on admission to the NICU.(2)
Many preterm infants have procedures performed soon after admission to the NICU; in 2019, 98% of infants born before 29 weeks' gestation at NMH had an umbilical venous catheter inserted. This may/often involve(s) prolonged periods of handling and potential exposure to cold.
The investigators prospectively studied a cohort of 26 infants < 32 weeks who had invasive procedures within 3 hours of birth performed in the NICU at NMH between November 2018 and June 2019. Almost three-quarters [19/26 (73%)] had an abnormal temperature at the beginning of the procedure; and 17/26 (65%) had an abnormal temperature at the end of the procedure. Only 3 (11%) infants maintained a normal temperature throughout the procedure. Perhaps more concerning is the severity of the hypothermia observed; 13 (50%) infants had a temperature < 36.0oC before and 11 (42%) after the procedure. The median duration of procedure was 53 (37, 73) minutes.(3)
The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomly assigned in blocks of 4 in a 1:1 ratio, stratified by GA (23 - 25+6, 26 - 28+6) and by admission temperature (normal temperature [36.5oC- 37.5oC] , abnormal temperature [<36.5oC or >37.5oC]).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Vascular access on admissionInsertion of peripheral venous catheter on admission to the NICU |
| Control | No intervention | –Insertion of and umbilical venous catheter on admission |
Who may qualify
- Ages
- 1 minute to 60 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- inborn infants admitted to the NICU with;
- gestational age < 29 weeks (up to 28+6 weeks) OR
- birth weight < 1250g.
Key exclusion criteria (3 listed)
- end of life (palliative) care
- large abdominal wall defects
- imperforate anus.
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 |
|---|---|---|
| Vascular access on admissionPIVC insertion | Procedure or surgery | Intervention |
Primary outcome
Core (rectal) temperature 2 hours after birth
Time frame: 2 hours
Core (rectal) temperature 2 hours after birth
27 secondary outcomes
Axillary temperature at the end of the procedure
Time frame: up to 24 hours
Mean difference in axillary temperature from admission to end of procedure
Time frame: up to 24 hours
Time to completion of procedure (incubator roof down, portholes closed and hands off)
Time frame: up to 24 hours
Time to first intravenous infusion starting (PN / dextrose / antibiotics / caffeine)
Time frame: up to 24 hours
Number (%) infants that have umbilical catheters inserted during their admission
Time frame: up to 24 hours
Number (%) lines used without repositioning
Time frame: up to 24 hours
Number (%) lines repositioned
Time frame: up to 24 hours
Number (%) of low lying umbilical venous catheters
Time frame: up to 24 hours
Number (%) of infants' in whom attempted placement of an umbilical line was not successful
Time frame: up to 24 hours
Number of peripheral line attempts
Time frame: up to 24 hours
Number (%) of infants in whom PIVC as first point of access was unsuccessful (nothing was infused through the line)
Time frame: 24 hours
Complications of line insertion/placement
Time frame: 10 days
Blood stream infections (CRBSI)
Time frame: up to 16 weeks
Number of x-rays performed in first 24 hours
Time frame: 24 hours
Blood sampling in first 24 hours
Time frame: 24 hours
Number of blood tests in 72 hours
Time frame: 3 days
Number of blood transfusions during hospital stay
Time frame: up to 26 weeks
Peripheral arterial line insertion in the first 7 days of life
Time frame: 7 days
PICC line insertion in the first 7 days of life
Time frame: 7 days
Inotropes administered in the first 72 hours of life
Time frame: 3 days
Intubation + Ventilation
Time frame: Up to 3 days
Surfactant administration
Time frame: up to 3 days
Necrotizing enterocolitis (Bell's staging)
Time frame: Up to 3 months
Intraventricular Haemorrhage (Papile classification)
Time frame: Up to 6 months
Periventricular leukomalacia
Time frame: Up to 6 months
Chronic lung disease
Time frame: Up to 3 months
In hospital mortality
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- 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.
Colm PF O'Donnell, MB BCh BAO principal investigator
The National Maternity Hospital
Lisa K McCarthy, MB BCh BAO principal investigator
The National Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular access on admission in people with Hypothermia, Newborn and Preterm Birth Complication, 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 3 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 28 Apr 2021. 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 Emma A Dunne, MB BCh BAO (0877799751, emma.dunne9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core (rectal) temperature 2 hours after birth (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2021.