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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01890668
First received: June 21, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Breast Feeding, Exclusive
Other: Osteopathic Manipulative Treatment
Other: No Osteopathic manipulative Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Efficacy assessment of osteopathic treatment on breastfeeding failure at 1 month of life. [ Time Frame: at 1 month of life. ] [ Designated as safety issue: No ]
    compare of breastfeeding failure percentage at one month of life between the two arms


Secondary Outcome Measures:
  • Compare IBFAT score (Infant Breast Feeding Assessment Tool score) [ Time Frame: at 10 days of life ] [ Designated as safety issue: No ]
    compare the IBFAT score between the two consultation Cs1(day 3) and Cs2 (day 10)

  • Maternal satisfaction assessment [ Time Frame: at one month of life ] [ Designated as safety issue: No ]
    assessment of maternal satisfaction between the Cs1, Cs2 and the visit at one month, by VAS

  • Safety assessment measured by per-treatment DAN score [ Time Frame: at 3 days of life ] [ Designated as safety issue: Yes ]
  • Preventive efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks [ Time Frame: at one month of life ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Description of breastfeeding initiation during the first month of life. [ Time Frame: at one month of life ] [ Designated as safety issue: No ]
  • Assessment of differential efficacy according osteopathic practitioner profile (age/experience, perinatal specialization…) [ Time Frame: at 10 days of life ] [ Designated as safety issue: No ]
  • Description of osteopathic dysfunctions frequencies diagnosed by osteopath. [ Time Frame: at 10 days of life ] [ Designated as safety issue: No ]
  • Safety assessment measured by per-treatment DAN score [ Time Frame: at 10 days of life ] [ Designated as safety issue: Yes ]
  • Curative efficacy of osteopathic treatment on nipple cracks, measured by the number of nipple cracks [ Time Frame: at one month of life ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Osteopathic Manipulative Treatment
Randomization and first OMT will take place at discharge (Day 3); second osteopathic therapy will be performed by the same osteopath practitioner at Day10.
Other: Osteopathic Manipulative Treatment

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

Placebo Comparator: Control group
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.
Other: No Osteopathic manipulative Treatment

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


  Eligibility

Ages Eligible for Study:   up to 4 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890668

Contacts
Contact: Jean-Baptiste MULLER, Dr jeanbaptiste.muller@chu-nantes.fr

Locations
France
Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant Recruiting
Nantes, France, 44093
Contact: Jean-Baptiste MULLER, Dr       jeanbaptiste.muller@chu-nantes.fr   
Principal Investigator: Jean-Baptiste MULLER, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Jean-Baptiste MULLER, Doctor Centre Hospitalier Universitaire de Nantes, France
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01890668     History of Changes
Other Study ID Numbers: RC12_0379
Study First Received: June 21, 2013
Last Updated: September 20, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Breastfeeding behaviour
OMT (Osteopathic Manipulative Treatment)
suboptimal infant breastfeeding behaviour
healthy newborns

ClinicalTrials.gov processed this record on September 22, 2014