Great Premature NewbornNOBOBONCT02872415
Effect of Site on Pain in Preterm Neonates
A study testing Blood puncture site in people with Great Premature Newborn, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have… Read more about this study
- Who is it for?
- Ages 3 to 72 hours
- Conditions the study is for
- Great Premature Newborn
- What is being tested?
- Blood puncture site
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2017to 25 May 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 3 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature neonates 23 to 32 weeks gestation
- Infant born with a postnatal age greater than or equal to 3 hours and less or equal to 72 hours
- Infant born with at least 3 blood glucose testing in less than 72 hours
Who cannot join
- Severe congenital anomalies that could alter pain perception or expression
- Extremities congenital anomaly impeding blood glucose testing on different sites
- Infants born to mothers known to be receiving opiates
- Severe haemodynamic disturb
- Severe neurologic injury
- Neonate with opioids or sedatives medications
- No parental consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.
Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have long-term neurocognitive influences. Repetitive procedural pain can also lead to changes in the pain sensitivity threshold therefore. The most common painful procedures are lancing for blood glucose testing. In adults, infants and term newborns, forearm blood glucose testing has been demonstrated to be less painful than conventional sites (heel, fingers). But data is lacking in preterm neonates.
The primary purpose of this study is to demonstrate a significant reduction in pain response during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born up to 32 weeks gestation.
Read more
This study is an interventional multicenter (3 centers), randomized, double bind trial with a cross over assignment. 60 premature neonates born between 23 to 32 weeks.
Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose pricks will be included. The different sites will be randomly successively tested.
- Conditions
- Great Premature Newborn
- Being tested
- Blood puncture site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood puncture siteBiological
Blood puncture site
| Study group | Role | What they receive |
|---|---|---|
| The forearm as blood puncture site | Experimental | The child receives a puncture blood on the forearm Receives: Biological: Blood puncture site |
| Fingers like blood puncture site | Placebo comparator | Premature receiving a puncture blood on the finger Receives: Biological: Blood puncture site |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain assessment
Painful response using Premature Infant Pain Profile (PIPP)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start10 May 2017
- Primary completion6 Apr 2018
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Great Premature NewbornStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872415
- Sponsor's protocol ID
- 2016-18
- Other IDs
- 2016-A01349-42
- Acronym
- NOBOBO
- Status last verified
- May 2023
- First submitted
- 16 Aug 2016
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.
- ClinicalTrials.gov ID
- NCT02872415
- Acronym / sponsor ID
- NOBOBO / 2016-18
- Conditions
- Great Premature Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 19 Aug 2016 (estimated)
- 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.
Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have long-term neurocognitive influences. Repetitive procedural pain can also lead to changes in the pain sensitivity threshold therefore. The most common painful procedures are lancing for blood glucose testing. In adults, infants and term newborns, forearm blood glucose testing has been demonstrated to be less painful than conventional sites (heel, fingers). But data is lacking in preterm neonates.
The primary purpose of this study is to demonstrate a significant reduction in pain response during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born up to 32 weeks gestation.
This study is an interventional multicenter (3 centers), randomized, double bind trial with a cross over assignment. 60 premature neonates born between 23 to 32 weeks.
Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose pricks will be included. The different sites will be randomly successively tested.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The forearm as blood puncture site | Experimental | Biological: Blood puncture siteThe child receives a puncture blood on the forearm |
| Fingers like blood puncture site | Placebo comparator | Biological: Blood puncture sitePremature receiving a puncture blood on the finger |
Who may qualify
- Ages
- 3 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Premature neonates 23 to 32 weeks gestation
- Infant born with a postnatal age greater than or equal to 3 hours and less or equal to 72 hours
- Infant born with at least 3 blood glucose testing in less than 72 hours
Key exclusion criteria (7 listed)
- Severe congenital anomalies that could alter pain perception or expression
- Extremities congenital anomaly impeding blood glucose testing on different sites
- Infants born to mothers known to be receiving opiates
- Severe haemodynamic disturb
- Severe neurologic injury
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 |
|---|---|---|
| Blood puncture siteBlood puncture site | Biological | Fingers like blood puncture site, The forearm as blood puncture site |
Primary outcome
The pain assessment
Time frame: 12 months
Painful response using Premature Infant Pain Profile (PIPP)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood puncture site in people with Great Premature Newborn, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 26 May 2023. 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 France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain assessment (time frame: 12 months). 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 26 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.