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Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants

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ClinicalTrials.gov Identifier: NCT02608151
Recruitment Status : Unknown
Verified October 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Ages and Stages Questionnaire [ Time Frame: 3, 6, 12, 18 and 24 months ]
    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.
  • 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 ]
    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].
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants
Official Title  ICMJE Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants
Brief 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.

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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Very Preterm Infant
Intervention  ICMJE
  • Other: 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) .
  • Other: massage without oil
Study Arms  ICMJE
  • Active Comparator: Touch massage without oil
    massage without oil
    Intervention: Other: massage without oil
  • Experimental: 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)
    Intervention: Other: massage with oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 16, 2015)
36
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 33 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02608151
Other Study ID Numbers  ICMJE 2011-08
RC12_3135 ( Other Identifier: APHM )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: urielle desalbres APHM
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP