Procedural PainPhase 3BMoSNCT00908401
Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants
A Phase 3 study testing Breastmilk and Oral Sucrose in people with Procedural Pain, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates. The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. Read more about this study
- Who is it for?
- Ages 3 to 10 days
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Breastmilk and Oral Sucrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Jul 2009
- Phase
- Phase 3
- 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 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm neonates born before 27 and 29+6 weeks GA
- blood sampling procedure
- obtention of parental consent
Who cannot join
- congenital malformation
- intravenous continuous analgesia
- contraindications to feed
- high grade intracerebral hemorrhage
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Creteil
Créteil, 94000
Elodie Zana, MD
About this study
Official title: Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.
The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.
- Conditions
- Procedural Pain
- Being tested
- Breastmilk, Oral Sucrose
- Keywords
- breastmilk, oral sucrose, analgesia, preterm neonates, Neonates
- Medical subject headings
- Pain, Procedural, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastmilkOther
Breastmilk: 0.2 ml
Oral SucroseOther
oral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier
| Study group | Role | What they receive |
|---|---|---|
| sucrose | Active comparator | This group will receive oral sucrose for procedural pain Receives: Other: Oral Sucrose |
| breastmilk | Experimental | this group will receive breastmilk as analgesic product to avoid procedural pain Receives: Other: Breastmilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose
Measured: One time during day 3 or 4 then day 7 to 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (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 Procedural PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Investigators
- Elodie Zana, MD, Principal investigator, Centre Hospitalier Intercommunal Creteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908401
- Sponsor's protocol ID
- CHICreteil
- Acronym
- BMoS
- Status last verified
- May 2009
- First submitted
- 22 May 2009
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5. doi: 10.1080/08035250410027959.
PubMed 15188969Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.
PubMed 12511452Carbajal R, Paupe A, Hoenn E, Lenclen R, Olivier-Martin M. [APN: evaluation behavioral scale of acute pain in newborn infants]. Arch Pediatr. 1997 Jul;4(7):623-8. doi: 10.1016/s0929-693x(97)83360-x. French.
PubMed 9295899
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT00908401
- Acronym / sponsor ID
- BMoS / CHICreteil
- Conditions
- Procedural Pain
- Keywords
- breastmilk, oral sucrose, analgesia, preterm neonates, Neonates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 25 May 2009 (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.
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.
The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sucrose | Active comparator | Other: Oral SucroseThis group will receive oral sucrose for procedural pain |
| breastmilk | Experimental | Other: Breastmilkthis group will receive breastmilk as analgesic product to avoid procedural pain |
Who may qualify
- Ages
- 3 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- preterm neonates born before 27 and 29+6 weeks GA
- blood sampling procedure
- obtention of parental consent
Key exclusion criteria (4 listed)
- congenital malformation
- intravenous continuous analgesia
- contraindications to feed
- high grade intracerebral hemorrhage
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 |
|---|---|---|
| BreastmilkBreastmilk: 0.2 ml | Other | breastmilk |
| Oral Sucroseoral sucrose: 0.2 ml one time 1 minute before the painful procedure with a pacifier | Other | sucrose |
Primary outcome
Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose
Time frame: One time during day 3 or 4 then day 7 to 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2009.
- Background: PubMed 15188969Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5. doi: 10.1080/08035250410027959.
- Background: PubMed 12511452Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.
- Background: PubMed 9295899Carbajal R, Paupe A, Hoenn E, Lenclen R, Olivier-Martin M. [APN: evaluation behavioral scale of acute pain in newborn infants]. Arch Pediatr. 1997 Jul;4(7):623-8. doi: 10.1016/s0929-693x(97)83360-x. French.
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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.
Elodie Zana, MD principal investigator
Centre Hospitalier Intercommunal Creteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Breastmilk and Oral Sucrose in people with Procedural Pain, run by Centre Hospitalier Intercommunal Creteil 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 4 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 25 May 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Elodie Zana, MD (+33 1 45 17 54 39, Elodie.Zana@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose (time frame: One time during day 3 or 4 then day 7 to 10). 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 NCT00908401, 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 25 May 2009.