Facilitated TuckingBABYDOULNCT02096822
Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants
A study testing Facilitated tucking + non-nutritive sucking and non-nutritive sucking in people with Facilitated Tucking and Non Nutritive Sucking, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Facilitated Tucking, Non Nutritive Sucking, Preterm
- What is being tested?
- Facilitated tucking + non-nutritive sucking and non-nutritive sucking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Aug 2015
- 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 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn from 28 weeks to 31 weeks +6 days GA.
- Age from 0 to 48 hours of life.
- Admission in intensive care unit or neonatal unit.
- Need for more than 4 heel stick procedures per 24 hours.
- One parents's consent
Who cannot join
- Hemodynamic instability with initropic drug need.
- Therapeutic Hypothermia in context of neonatal asphyxia.
- Curarized child.
- Neurologic anomaly of contact/tonus.
- Lidocaine application during the 4 hours before the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Facilited Tucking and Non-nutritive Sucking of Sterile Water to Relieve Preterm Infants From Pain During Heel-stick Procedures.
Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.
Read the detailed description
After randomization, baby will receive heel stick procedure with either non-nutritive sucking and sterile water or non-nutritive sucking and sterile water combined with facilited tucking. The sequence will be filmed. Evaluation of PIPP and DAN will be done after viewing by 3 independent experts. Each child will receive only one procedure.
- Conditions
- Facilitated Tucking, Non Nutritive Sucking, Preterm, Pain Relief
- Being tested
- Facilitated tucking + non-nutritive sucking, non-nutritive sucking
- Keywords
- Facilitated tucking, Non nutritive sucking, Preterm, Pain relief
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated tucking + non-nutritive suckingBehavioural
non-nutritive suckingOther
| Study group | Role | What they receive |
|---|---|---|
| non-nutritive sucking alone | Active comparator | After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water. Receives: Other: non-nutritive sucking |
| Facilitated tucking + non-nutritive sucking | Experimental | After randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water combined with facilited tucking. Receives: Behavioral: Facilitated tucking + non-nutritive sucking |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIPP (Premature Infant Pain Profile)
Behavioural measure of pain for premature infants.
Indicators:
- gestational age
- behavioural state before painful stimulus
- change in heart rate during painful stimulus
- change in oxygen saturation during painful stimulus
- brow bulge during painful stimulus
- eye squeeze during painful stimulus
- nasolabial furrow during painful stimulus
Measured: 15 sec before to 30 sec after heel-lance procedure
Secondary outcomes (1)
DAN (Douleur Aigue Nouveau-né)
Behavioural measure of pain for premature infants
Indicators:
Facial movement Members movement Vocal expression
Measured: 15 sec before to 3 min after heel-lance procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facilitated TuckingStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Perroteau, Nurse, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096822
- Sponsor's protocol ID
- K13802
- Other IDs
- PHRI 13335
- Acronym
- BABYDOUL
- Status last verified
- Feb 2016
- First submitted
- 24 Mar 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Facilited Tucking and Non-nutritive Sucking of Sterile Water to Relieve Preterm Infants From Pain During Heel-stick Procedures.
- ClinicalTrials.gov ID
- NCT02096822
- Acronym / sponsor ID
- BABYDOUL / K13802
- Conditions
- Facilitated Tucking, Non Nutritive Sucking, Preterm, Pain Relief
- Keywords
- Facilitated tucking, Non nutritive sucking, Preterm, Pain relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 26 Mar 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.
Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.
Detailed description
After randomization, baby will receive heel stick procedure with either non-nutritive sucking and sterile water or non-nutritive sucking and sterile water combined with facilited tucking. The sequence will be filmed. Evaluation of PIPP and DAN will be done after viewing by 3 independent experts. Each child will receive only one procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-nutritive sucking alone | Active comparator | Other: non-nutritive suckingAfter randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water. |
| Facilitated tucking + non-nutritive sucking | Experimental | Behavioral: Facilitated tucking + non-nutritive suckingAfter randomization, baby will receive heel stick procedure with non-nutritive sucking and sterile water combined with facilited tucking. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Newborn from 28 weeks to 31 weeks +6 days GA.
- Age from 0 to 48 hours of life.
- Admission in intensive care unit or neonatal unit.
- Need for more than 4 heel stick procedures per 24 hours.
- One parents's consent
Key exclusion criteria (5 listed)
- Hemodynamic instability with initropic drug need.
- Therapeutic Hypothermia in context of neonatal asphyxia.
- Curarized child.
- Neurologic anomaly of contact/tonus.
- Lidocaine application during the 4 hours before the procedure
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 |
|---|---|---|
| Facilitated tucking + non-nutritive sucking | Behavioural | Facilitated tucking + non-nutritive sucking |
| non-nutritive sucking | Other | non-nutritive sucking alone |
Primary outcome
PIPP (Premature Infant Pain Profile)
Time frame: 15 sec before to 30 sec after heel-lance procedure
Behavioural measure of pain for premature infants. Indicators: * gestational age * behavioural state before painful stimulus * change in heart rate during painful stimulus * change in oxygen saturation during painful stimulus * brow bulge during painful stimulus * eye squeeze during painful stimulus * nasolabial furrow during painful stimulus
1 secondary outcome
DAN (Douleur Aigue Nouveau-né)
Time frame: 15 sec before to 3 min after heel-lance procedure
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 24 Feb 2016.
Related trials for Facilitated Tucking
Recruiting
Swaddling and Facilitated Tucking During Nasal CPAP Application
Respiratory Disease of A Newborn
Recruiting
Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants
Infant, Premature, Kangaroo Mother Care
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.
Anne Perroteau, Nurse principal investigator
Assistance Publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated tucking + non-nutritive sucking and non-nutritive sucking in people with Facilitated Tucking and Non Nutritive Sucking, 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 5 inclusion and 5 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 24 Feb 2016. 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.
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?
PIPP (Premature Infant Pain Profile) (time frame: 15 sec before to 30 sec after heel-lance procedure). 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 24 Feb 2016.