Efficacy of an Osteopathic Treatment for Mechanical Sucking Dysfunctions in Newborn

NCT02407860 | Completed

• 1 other identifier: 14-116
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Breastfeeding is the physiological and recommended way of feeding newborns as indicated by the World Health Organization, Health Canada and the politics of perinatality 2008-2018 in Quebec. Despite these, mothers who exclusively breastfed their babies are rare. According to Statistics Canada, the first month of life is the most at risk time to wean because of technical difficulties (53% of weaning) including mechanical issues. In Quebec city, despite a supportive network of health care professionals including lactation consultant, many babies are weaned. Lactation consultant are often feeling helpless when facing these mechanical difficulties. The purpose of this study is to determine the efficiency of an osteopathic treatment for newborns presenting breastfeeding mechanical difficulties. The investigators' hypotheses is that an osteopathic treatment integrating in the usual care is more efficient than usual car alone to help healing mechanical breastfeeding issues. The investigators propose a randomized clinical trial on a sample of 90 babies (45 in each group), under six weeks, presenting sucking dysfunctions, in Quebec city (Canada). The control group will receive usual care with a lactation consultant and the intervention group will receive usual care plus an osteopathic treatment. It is a simple blind clinical trial: the osteopath finds out, prior to evaluating the patient, what intervention should be delivered to the baby (assessment alone or standardized osteopathic treatment for infant). The results will ultimately lead to improvements in the existing knowledge on the fields of osteopathy and lactation support, allowing implementation of osteopathic care in the perinatal network.

Conditions

Breastfeeding

Keywords

breast feeding; sucking; dysfunction; Latch assessment tool; visual analogic scale; infant physiology

Outcome Measures

Primary Outcomes (1)

• Change from baseline in baby's latch at the breast

  Latch assessment tool (Jensen, Wallace \& Kelsay; 1994)

  Immediately after the intervention and 2 days post-intervention

Secondary Outcomes (5)

• Change from baseline in numbers of feeds per day

  Immediately after the intervention and 2, and 10 days post-intervention

• Change from baseline in devices used to feed the baby

  2 and 10 days post-intervention

• Change from baseline in mother's nipple pain

  Immediately after the intervention and 2, and 10 days post-intervention

• Change from baseline in baby's head rotation

  Immediately after the intervention

• Mother's satisfaction with an osteopathic approach

  10 days post-intervention

Study Arms (2)

treatment

EXPERIMENTAL

one single osteopathic treatment in addition to usual breastfeeding counselling

Other: osteopathic treatment

control

ACTIVE COMPARATOR

usual breastfeeding counselling. Osteopathic evaluation of entire body

Other: usual breastfeeding counselling

Interventions

osteopathic treatment OTHER

Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.

treatment

usual breastfeeding counselling OTHER

breastfeeding counselling and support by lactation consultant

control

Eligibility Criteria

• Age: 48 Hours - 6 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy term newborn,
• mechanical suckling dysfunction, assessed by lactation consultant or midwives or healthcare professionals with breastfeeding experience.

You may not qualify if:

• breastfeeding difficulties from mother (hypogalactia, breast hypoplasia, medication),
• twins or more,
• tongue-tie or lip tie pending for surgical treatment,
• previous or current bodywork (chiropractic, osteopathy, physiotherapy, ergotherapy, craniosacral therapy).

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Entraide Naturo-Lait

Québec, Quebec, G1S 3S5, Canada

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Isabelle Gaboury, PhD

  Université de Sherbrooke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: April 3, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

CA (1)