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

NCT02608151 | Unknown

• 2 other identifiers: 2011-08RC12_3135
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Preterm Infant

Keywords

neurodevelopement; Very preterm infant

Outcome Measures

Primary Outcomes (1)

• 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.

  12-20 weeks post-term

Secondary Outcomes (2)

• Ages and Stages Questionnaire

  3, 6, 12, 18 and 24 months

• lipid profile

  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

Study Arms (2)

Touch massage without oil

ACTIVE COMPARATOR

massage without oil

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)

Other: massage with oil

Interventions

massage with oil OTHER

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) .

touch massage with oil

massage without oil OTHER

Touch massage without oil

Eligibility Criteria

• Age: Up to 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

APHM

Marseille, France

Location

MeSH Terms

Interventions

Massage; Oils

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Lipids

Study Officials

• urielle desalbres

  APHM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: November 18, 2015
• Study Start: September 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2016
• Last Updated: November 18, 2015

Record last verified: 2015-10

Locations

FR (1)