Preterm NewbornsELAPPSNCT02147717
Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation
A study testing Laser stimulation and Fake laser stimulation in people with Preterm Newborns, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the effect of laser acupuncture in the treatment of perioperative pain during tracheal suction after patent ductus arteriosus ligation in preterm infants. Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Preterm Newborns
- What is being tested?
- Laser stimulation and Fake laser stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to May 2017
- 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 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant born between 24 +0 and 32 +6 j GA
- Ductus arteriosus surgery scheduled in Robert Debré hospital
- Informed consent of the holders of the exercise of parental authority
- Child beneficiary of a social security scheme (excluding AME)
Who cannot join
- Obvious underlying disease (genetic, metabolic)
Trial locations and contacts
1 site in 1 country.
About this study
Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the effect of laser acupuncture in the treatment of perioperative pain during tracheal suction after patent ductus arteriosus ligation in preterm infants.
Read the detailed description
management of pain in preterm infants is essential because it is exposed to repetitive movements painful and invasive miners such as surgical treatment of the ductus arteriosus which is accompanied by respiratory instability, increased consumption analgesics. Acupuncture has shown its analgesic efficacy in numerous studies in children and adults. Acupuncture (laser) is a simple, fast method without side effect used in children, but no study exists on the effect of acupuncture in the treatment of perioperative pain in addition to pharmacologic agents in preterm infants. Hypothesis: acupuncture reduce pain and discomfort after surgery of the ductus arteriosus in preterm infants in addition to pharmacologic agents
Main objective:
Assessing the contribution of laser acupuncture on the pain management during endotracheal suctioning (ETS) after surgery ductus arteriosus in preterm infants
- Conditions
- Preterm Newborns
- Being tested
- Laser stimulation, Fake laser stimulation
- Keywords
- preterm newborns, Transfontanellar ultrafast doppler, Acupuncture, perioperative pain, surgery of the ductus arteriosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser stimulationDevice
Infants will be divided in 2 groups:
- Placebo group: Placebo (fake laser stimulation) plus opioid treatment before ETS
- Experimental group: Laser stimulation plus opioid treatment before ETS. Low level laser acupuncture, 670 nm, 10Hz, 0,3 J per acupoint, 6 points per neonate (Zu san li, He Gu, Nei Guan) marquage CE, premio 30 laser duo de Sedatelec. Overall 3 minutes of treatment.
This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery)
Fake laser stimulationDevice
newborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage
| Study group | Role | What they receive |
|---|---|---|
| Laser stimulation | Experimental | Laser stimulation plus opioid treatment before ETS. Low level laser acupuncture, 670 nm, 10Hz, 0,3 J per acupoint, 6 points per neonate (Zu san li, He Gu, Nei Guan) marquage CE, premio 30 laser duo de Sedatelec. Overall 3 minutes of treatment.
This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery) Receives: Device: Laser stimulation |
| fake laser stimulation | Placebo comparator | newborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage Receives: Device: Fake laser stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral pain scale (COMFORT scale)
Behavioral pain scale (COMFORT scale) studied at a painful procedure (endotracheal suctioning, ETS) with a regular assessment in perioperative. All the ETS will videotaped with a color digital camera by the research assistant.
Measured: 48 hours post-operative
Secondary outcomes (3)
Behavioral pain scale (DAN scale and EDIN scale)
Behavioral pain scale during ETS (DAN scale) and after ETS (EDIN scale)
Measured: 48hours postoperative
Consumption of morphine
Consumption of morphine (cumulative mg / kg dose) from surgery to 48h postoperative
Measured: 48 hours postoperative
Measurement of FIO2
Measurement of FIO2, mode of mechanical ventilation after surgery
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm NewbornsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Biran Valérie, PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147717
- Sponsor's protocol ID
- P 130602
- Acronym
- ELAPPS
- Status last verified
- Aug 2016
- First submitted
- 19 May 2014
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation
- ClinicalTrials.gov ID
- NCT02147717
- Acronym / sponsor ID
- ELAPPS / P 130602
- Conditions
- Preterm Newborns
- Keywords
- preterm newborns, Transfontanellar ultrafast doppler, Acupuncture, perioperative pain, surgery of the ductus arteriosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 May 2014 (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.
Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the effect of laser acupuncture in the treatment of perioperative pain during tracheal suction after patent ductus arteriosus ligation in preterm infants.
Detailed description
management of pain in preterm infants is essential because it is exposed to repetitive movements painful and invasive miners such as surgical treatment of the ductus arteriosus which is accompanied by respiratory instability, increased consumption analgesics. Acupuncture has shown its analgesic efficacy in numerous studies in children and adults. Acupuncture (laser) is a simple, fast method without side effect used in children, but no study exists on the effect of acupuncture in the treatment of perioperative pain in addition to pharmacologic agents in preterm infants. Hypothesis: acupuncture reduce pain and discomfort after surgery of the ductus arteriosus in preterm infants in addition to pharmacologic agents
Main objective:
Assessing the contribution of laser acupuncture on the pain management during endotracheal suctioning (ETS) after surgery ductus arteriosus in preterm infants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser stimulation | Experimental | Device: Laser stimulationLaser stimulation plus opioid treatment before ETS. Low level laser acupuncture, 670 nm, 10Hz, 0,3 J per acupoint, 6 points per neonate (Zu san li, He Gu, Nei Guan) marquage CE, premio 30 laser duo de Sedatelec. Overall 3 minutes of treatment. This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery) |
| fake laser stimulation | Placebo comparator | Device: Fake laser stimulationnewborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infant born between 24 +0 and 32 +6 j GA
- Ductus arteriosus surgery scheduled in Robert Debré hospital
- Informed consent of the holders of the exercise of parental authority
- Child beneficiary of a social security scheme (excluding AME)
Key exclusion criteria (1 listed)
- Obvious underlying disease (genetic, metabolic)
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 |
|---|---|---|
| Laser stimulationInfants will be divided in 2 groups: * Placebo group: Placebo (fake laser stimulation) plus opioid treatment before ETS * Experimental group: Laser stimulation plus opioid treatment before ETS. Low level laser acupuncture, 670 nm, 10Hz, 0,3 J per acupoint, 6 points per neonate (Zu san li, He Gu, Nei Guan) marquage CE, premio 30 laser duo de Sedatelec. Overall 3 minutes of treatment. This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery) | Device | Laser stimulation |
| Fake laser stimulationnewborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage | Device | fake laser stimulation |
Primary outcome
Behavioral pain scale (COMFORT scale)
Time frame: 48 hours post-operative
Behavioral pain scale (COMFORT scale) studied at a painful procedure (endotracheal suctioning, ETS) with a regular assessment in perioperative. All the ETS will videotaped with a color digital camera by the research assistant.
3 secondary outcomes
Behavioral pain scale (DAN scale and EDIN scale)
Time frame: 48hours postoperative
Consumption of morphine
Time frame: 48 hours postoperative
Measurement of FIO2
Time frame: 48 hours postoperative
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 25 Jul 2017.
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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.
Biran Valérie, PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser stimulation and Fake laser stimulation in people with Preterm Newborns, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 1 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 25 Jul 2017. 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?
Behavioral pain scale (COMFORT scale) (time frame: 48 hours post-operative). 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 25 Jul 2017.