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Completed

NCT Number: NCT01890668

Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour

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.

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Key information

Conditions

Breast Feeding, Exclusive Behavior Breast Feeding Feeding Behavior

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteopathic manipulative treatment

Other

Visit 1 between H60 and discharge :

Interview (pregnancy step, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam (osteopathic specific diagnosis, mobility…) Osteopathic Manipulative Treatment by sweet osteopathic mobilization Time of intervention = 30 to 45 min Visit 2 : 7 days after visit 1 (+/- 24H) with the same procedure

To keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility.

A telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data.

Two others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date.

The follow-up for each patient is 6 months

No Osteopathic manipulative Treatment

Other

Visit 1 between H60 and discharge :

Interview (pregnancy steps, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam and Treatment will not be realized. Newborn will be undressed, lying naked (covered with polar sheet) on the exam table, dissimulated to parents by adequate screen. The osteopathic procedure will take place on a dolly to mimic from an indiscernible manner, osteopathic management.

Time of intervention = 30 to 45 min Visit 2: 7 days after visit 1 (+/- 24H) with the same procedure.

To keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility.

A telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data.

Two others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date.

The follow-up for each patient is 6 months

Primary outcomes

  1. Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life.

    Time frame: at 1 month of life.

    compare of breastfeeding failure percentage at one month of life between the two arms

Secondary outcomes

  1. Compare IBFAT score (Infant Breast Feeding Assessment Tool score)

    Time frame: at 10 days of life

    compare the IBFAT score between the two consultation Cs1(day 3) and Cs2 (day 10)

  2. Maternal satisfaction assessment

    Time frame: at one month of life

    assessment of maternal satisfaction between the Cs1, Cs2 and the visit at one month, by VAS

  3. Safety assessment measured by per-treatment DAN score

    Time frame: at 3 days of life

  4. Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks

    Time frame: at one month of life

  5. Description of newborns behaviour during the first month of life (sleeping/awakening rhythm, cries and breastfeeding durations etc…) according treatment arm.

    Time frame: at one month of life

  6. Description of breastfeeding initiation during the first month of life.

    Time frame: at one month of life

  7. Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…)

    Time frame: at 10 days of life

  8. Description of osteopathic dysfunctions frequencies diagnosed by osteopath.

    Time frame: at 10 days of life

  9. Safety assessment measured by per-treatment DAN score

    Time frame: at 10 days of life

  10. Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks

    Time frame: at one month of life

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Efficacy Assessment of Early Osteopathic Manipulative Treatment (OMT) in the Management of Suboptimal Breastfeeding Behaviour in Healthy Newborns. A Prospective Monocentric Randomized Double-blinded Study.

Acronym: NEOSTEO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2013
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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