Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-02 @ 2:40 AM
Study NCT ID:
NCT02608151
Status:
UNKNOWN
Last Update Posted:
2015-11-18
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect in the Short and Medium Term of Different Techniques of Tactile Stimulations on Neurological Development in a Population of Very Preterm Infants
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RC12_3135 | OTHER | APHM | View |