Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour (NEOSTEO)

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Breast Feeding, Exclusive

Treatments

Other: Osteopathic Manipulative Treatment
Other: No Osteopathic manipulative Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01890668
RC12_0379

Details and patient eligibility

About

Breastfeeding is one of the prime factors of long-term health protection in newborns, for nutritional, immunological and developmental reasons. In France there is a wide inter-regional variability of breastfeeding rates at discharge. This variability associates different factors involving both, mothers, birth conditions, newborns and mother-child couple. Some approaches, including osteopathy, aim to support early breastfeeding difficulties. As many others non-conventional medicines, there is a huge and growing interest for this alternative therapy and a spontaneous recourse in the first months of life. Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to evaluate for the first time in France, in a randomized, double-blinded design, the efficacy of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour healthy newborns. 128 couples mother-child will be randomized in two groups: with or without osteopathic intervention on the newborn.

Enrollment

128 patients

Sex

All

Ages

1 to 4 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Healthy newborn ≥ 38 weeks of gestation,
  • Suboptimal breastfeeding behavior defined by an IBFATmax score <10 after 2 assessments.(IBFATmax score = maximal score of Infant Breast Feeding Assessment Tool)
  • And/ or presence of persistent severe pain (VAS> 5) at hospital discharge,
  • And / or the presence of nipples cracks, grades 2-5 on the NTS scale
  • Maternal Project of exclusive breastfeeding.
  • Parental informed and consent form signed

Exclusion criteria

  • Prematurity defined by a gestation <38 weeks
  • Hypotrophy
  • Maternal obesity (BMI>40)
  • Multiple pregnancy
  • Congenital malformation
  • Neonatal pathology incompatible with efficient lactation initiation.
  • Mothers minor or major and / or under guardianship and / or with poor understanding of French language
  • Previous history of maternal breast surgery or umbilicated nipple
  • IBFAT score max >10 on at least one of the two assessment at Day3.
  • Medical contraindication to osteopathy: bone injury (fracture), tendon or ligament (sprain, dislocation etc ...) in the newborn incompatible with effective mobilization.
  • Parental consent withdrawal.
  • Neonatal pathology incompatible with breastfeeding follow-up in the first month of life.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

128 participants in 2 patient groups, including a placebo group

Osteopathic Manipulative Treatment
Experimental group
Description:
Randomization and first OMT will take place at discharge (Day 3); second osteopathic therapy will be performed by the same osteopath practitioner at Day10.
Treatment:
Other: Osteopathic Manipulative Treatment
Control group
Placebo Comparator group
Description:
Control group consists in classical medical and paramedical breastfeeding support. OMT on the newborn will be realized by osteopath dissimulated behind a screen. Placebo OMT consists to mimic, without the knowledge of parents, osteopathic techniques on a dolly.
Treatment:
Other: No Osteopathic manipulative Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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