Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants
NCT ID: NCT02608151
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2011-09-30
2016-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Touch massage without oil
massage without oil
massage without oil
touch massage with oil
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)
massage with oil
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) .
Interventions
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massage with oil
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 oil
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* 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.
33 Weeks
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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urielle desalbres
Role: STUDY_DIRECTOR
APHM
Locations
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APHM
Marseille, , France
Countries
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Other Identifiers
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RC12_3135
Identifier Type: OTHER
Identifier Source: secondary_id
2011-08
Identifier Type: -
Identifier Source: org_study_id