Very Preterm InfantNCT02608151
Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants
A study testing massage with oil and massage without oil in people with Very Preterm Infant, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage pressure with kinesthetic movement significantly increases the weight, bone density and shorten the duration of stay of premature babies who benefits. Read more about this study
- Who is it for?
- Ages Up to 33 weeks
- Conditions the study is for
- Very Preterm Infant
- What is being tested?
- massage with oil and massage without oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Apr 2016
- 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 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children whose term of birth is between 26 and 31 weeks of amennorhea
- Children's age less than or equal to 33 weeks of postnatal age
- Children without neurological pathologies (intra ventricular hemorrhage grade 1 or 2 of the papilla transfontanellar ultrasound [Papille 1978] and / or brain abnormalities on MRI type of 1-4 according to modified Paneth classification [Paneth 1999]);
- Children whose parenteral nutrition is less than 60 cc / kg / day;
- Children without infectious disease clinically unstable ( C reactive protein below 7);
- Children without CPAP (Positive Airway Pressure Control) nasal for at least 48 hours;
- Children do not present a genetic syndrome, progressive neurological disease, malformation pathology, a cleft lip and palate;
- Children with one parent or legal representatives are beneficiaries of a social security regimen;
Who cannot join
- Children under 26 and more than 32 weeks of amenorrhea;
- Children not included at 34 weeks of amenorrhea;
- Children with high-grade intraventricular hemorhage (grade 3-4) [Papille 1978] and / or abnormality of cerebral MRI (grade 5 and 6) [Paneth 1999];
- Children with a necrotizing enterocolitis or nosocomial infection;
- Children with a genetic syndrome, a progressive neurological disease, malformation pathology, a cleft lip and palate.
Trial locations and contacts
1 site in 1 country.
About this study
Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage pressure with kinesthetic movement significantly increases the weight, bone density and shorten the duration of stay of premature babies who benefits.
Studies using vegetable oils show an increase in the effect on weight gain by cutaneous absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin mechanoreceptors) since it is found in children stimulated an increase in the vagal activity, acceleration of gastric emptying and an increase in the secretion of insulin and IGF1.
Read more
Few studies have evaluated the effects of massage on the medium-term neurological development in preterm infants and the effect of the essential oils in the effectiveness of touching the short and medium term massage.
The aim of the investigators study is to evaluate the neurological development in the short and medium term in premature newborns and biological effects of massage with essential use of vegetable oil.
Methodology and possible collaborations This is a monocentric, randomized, controlled, in a neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment is administered 10 minutes twice a day for 10 consecutive days watching for signs of intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age corrected is used as the first neurological assessment criterion.
The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.) is used to 6, 12, 24 months corrected age and completed by the parents as a second neurological endpoint.
A lipid chromatography is performed at the beginning and at the end of the massage time and at the deliverance from NICU for comparing the profile of children's fatty acids.
Expected results Show that there is an improvement in the neurological development in children who received massage with vegetable oil ISIO 4. Show that there is a skin absorption of essential fatty acids that can substitute for a known major deficiency in premature even in infants fed breast milk.
- Conditions
- Very Preterm Infant
- Being tested
- massage with oil, massage without oil
- Keywords
- neurodevelopement, Very preterm infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage with oilOther
Application or not of an oil consisting of 4 vegetable oils (40% sunflower oil, 3% grape seed oil, 1.5% coriander oil, and 57% of rapeseed oil) during the massage. This oil was chosen due to its composition of essential fatty acids (60%) including: linoleic acid (omega 6,25g 100 g)), linolenic acid (omega 3 5.3g to 100 g) and tocopherol (vitamin E) .
massage without oilOther
| Study group | Role | What they receive |
|---|---|---|
| Touch massage without oil | Active comparator | massage without oil Receives: Other: massage without oil |
| touch massage with oil | Experimental | massage with an oil consisting of 4 vegetable oils (40% sunflower oil, 3% grape seed oil, 1.5% coriander oil, and 57% of rapeseed oil) Receives: Other: massage with oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of spontaneous movements assessed by motor repertoire score following Prechtl's method
The primary outcome is represented by the assessment of neuro-development of children from 3 months of age corrected more precisely between 12 and 20 weeks post-term. The evaluation of neuro-development will be realized from measurement of the quality of spontaneous general movement. The motor repertoire was evaluated using the video-recording made between 11 to 16 weeks post-term, following Prechtl's method for the assessment of the motor repertoire between 3 and 5 months. Scores were assigned to the following five aspects: Quality of FMs, Age-adequacy of concurrent movements, Presence and normality of concurrent movements, Presence and normality of postural patterns and Quality of concurrent movements. Scores for each aspect can range from 1 to 4. The scores for the five aspects of the motor repertoire are summed to provide a Motor Optimality Score, range 5 to 20. Higher scores indicate higher movement quality.
Measured: 12-20 weeks post-term
Secondary outcomes (2)
Ages and Stages Questionnaire
The evaluation of neuro-development between 12 and 20 weeks post term from motor score will be complemented by an assessment using the questionnaire "Ages and Stages Questionnaire" (ASQ) at 3, 6, 12, 18 and 24 months. The ASQ [Bricker and Squires 2000] questionnaire is a child developmental delay screening tool, thus identifying children in need of a thorough assessment of their development.
Measured: 3, 6, 12, 18 and 24 months
lipid profile
The assessment of the lipid profile will be done by analysis of fatty acid profiles of plasma and red blood cells premature by gas chromatography [Ohta 1990].
Measured: before the procedure (massage program), at the end of the procedure (massage program) and through study completion, an average of 39-40 weeks of amenorrhea corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Preterm InfantStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- urielle desalbres, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608151
- Sponsor's protocol ID
- 2011-08
- Other IDs
- RC12_3135
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants
- ClinicalTrials.gov ID
- NCT02608151
- Acronym / sponsor ID
- 2011-08
- Conditions
- Very Preterm Infant
- Keywords
- neurodevelopement, Very preterm infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 18 Nov 2015 (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.
Premature birth deprives infants of sensory stimulation. Tactile stimulation such as massage pressure with kinesthetic movement significantly increases the weight, bone density and shorten the duration of stay of premature babies who benefits.
Studies using vegetable oils show an increase in the effect on weight gain by cutaneous absorption. The mechanism is probably vagal (stimulation of baroreceptors and skin mechanoreceptors) since it is found in children stimulated an increase in the vagal activity, acceleration of gastric emptying and an increase in the secretion of insulin and IGF1.
Few studies have evaluated the effects of massage on the medium-term neurological development in preterm infants and the effect of the essential oils in the effectiveness of touching the short and medium term massage.
The aim of the investigators study is to evaluate the neurological development in the short and medium term in premature newborns and biological effects of massage with essential use of vegetable oil.
Methodology and possible collaborations This is a monocentric, randomized, controlled, in a neonatal intensive care unit. It concerns 60 children born between 26 and 30 weeks of amenorrhea. Each child receives massage randomized with or without oil ISIO 4. The treatment is administered 10 minutes twice a day for 10 consecutive days watching for signs of intolerance. The quality of the spontaneous motility between 12 and 20 weeks of age corrected is used as the first neurological assessment criterion.
The questionnaire (ASQ) Bricker and Squires (translated into French by Martha Bonin et al.) is used to 6, 12, 24 months corrected age and completed by the parents as a second neurological endpoint.
A lipid chromatography is performed at the beginning and at the end of the massage time and at the deliverance from NICU for comparing the profile of children's fatty acids.
Expected results Show that there is an improvement in the neurological development in children who received massage with vegetable oil ISIO 4. Show that there is a skin absorption of essential fatty acids that can substitute for a known major deficiency in premature even in infants fed breast milk.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Touch massage without oil | Active comparator | Other: massage without oilmassage without oil |
| touch massage with oil | Experimental | Other: massage with oilmassage with an oil consisting of 4 vegetable oils (40% sunflower oil, 3% grape seed oil, 1.5% coriander oil, and 57% of rapeseed oil) |
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children whose term of birth is between 26 and 31 weeks of amennorhea
- Children's age less than or equal to 33 weeks of postnatal age
- Children without neurological pathologies (intra ventricular hemorrhage grade 1 or 2 of the papilla transfontanellar ultrasound [Papille 1978] and / or brain abnormalities on MRI type of 1-4 according to modified Paneth classification [Paneth 1999]);
- Children whose parenteral nutrition is less than 60 cc / kg / day;
- Children without infectious disease clinically unstable ( C reactive protein below 7);
Key exclusion criteria (5 listed)
- Children under 26 and more than 32 weeks of amenorrhea;
- Children not included at 34 weeks of amenorrhea;
- Children with high-grade intraventricular hemorhage (grade 3-4) [Papille 1978] and / or abnormality of cerebral MRI (grade 5 and 6) [Paneth 1999];
- Children with a necrotizing enterocolitis or nosocomial infection;
- Children with a genetic syndrome, a progressive neurological disease, malformation pathology, a cleft lip and palate.
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 |
|---|---|---|
| massage with oilApplication or not of an oil consisting of 4 vegetable oils (40% sunflower oil, 3% grape seed oil, 1.5% coriander oil, and 57% of rapeseed oil) during the massage. This oil was chosen due to its composition of essential fatty acids (60%) including: linoleic acid (omega 6,25g 100 g)), linolenic acid (omega 3 5.3g to 100 g) and tocopherol (vitamin E) . | Other | touch massage with oil |
| massage without oil | Other | Touch massage without oil |
Primary outcome
Quality of spontaneous movements assessed by motor repertoire score following Prechtl's method
Time frame: 12-20 weeks post-term
The primary outcome is represented by the assessment of neuro-development of children from 3 months of age corrected more precisely between 12 and 20 weeks post-term. The evaluation of neuro-development will be realized from measurement of the quality of spontaneous general movement. The motor repertoire was evaluated using the video-recording made between 11 to 16 weeks post-term, following Prechtl's method for the assessment of the motor repertoire between 3 and 5 months. Scores were assigned to the following five aspects: Quality of FMs, Age-adequacy of concurrent movements, Presence and normality of concurrent movements, Presence and normality of postural patterns and Quality of concurrent movements. Scores for each aspect can range from 1 to 4. The scores for the five aspects of the motor repertoire are summed to provide a Motor Optimality Score, range 5 to 20. Higher scores indicate higher movement quality.
2 secondary outcomes
Ages and Stages Questionnaire
Time frame: 3, 6, 12, 18 and 24 months
lipid profile
Time frame: before the procedure (massage program), at the end of the procedure (massage program) and through study completion, an average of 39-40 weeks of amenorrhea corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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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.
urielle desalbres study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage with oil and massage without oil in people with Very Preterm Infant, 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 8 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: status not confirmed, as of the sponsor's last update on 18 Nov 2015. 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?
Results are not available in the source record.
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?
Quality of spontaneous movements assessed by motor repertoire score following Prechtl's method (time frame: 12-20 weeks post-term). 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 18 Nov 2015.