Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour

NACompletedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
Breast Feeding, Exclusive
Interventions
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"

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"

Trial Locations (1)

44093

Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant, Nantes

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT01890668 - Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour | Biotech Hunter | Biotech Hunter