PREMASS: Evaluation of the Risks and Benefits of Abdominal Massage Treatment in Neonatalogy in Premature Children

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT03681782
Collaborator
(none)
60
1
43
1.4

Study Details

Study Description

Brief Summary

Premature birth creates difficulties for the child in starting his diet and digestion. The immaturity of the major vital functions complicates the abdominal transit. The initial diet, essentially parenteral in the central way, decreases progressively according to the digestive tolerance allowing the increase of the enteral feedings to optimize the growth. To ensure this transition, nurses nurses in Neonatology service, through their knowledge and expertise, practice a daily gesture: abdominal massage-care. This prevents or remedies a slowing of transit. The paramedical clinical examination of the child, determines the realization of this care. Several studies have proved the benefit of massage on the weight gain of premature babies. These stimulate peristalsis, decrease the duration of intestinal transit and the sensations of discomfort and pain related to it. Currently in Neonatology, developmental care (NIDCAP) is an approach to individualized care for the premature to improve its evolution. The fine observation of his behavior allows us to adapt our care and to ensure the respect of his pace. However, the first sensory capacity developed in the fetus, the touch can also be a source of over-stimulation for the premature baby. Moreover, the greater the prematurity, the greater the risk of occurrence of digestive complications. Can the abdominal care-massage in premature babies be harmful or risk increasing existing symptoms? The abdominal care-massage is neither described nor referenced in the nomenclature of nursing, neither taught nor subject to medical prescription.

Few publications exist on this subject, no large-scale research has been reported. On the other hand, the perception of our empirical practice seems to show that the abdominal massage-care is an important aid to the smooth transit of the premature newborn. Transmitted orally by professionals to newcomers to Neonatology, this treatment is carried out in a heterogeneous manner according to professionals. Convinced of its effectiveness, carers wonder about their practice: is there an optimal technique without risk for the child? Determining the absence of risk and the effectiveness of the abdominal care-massage suggests a wider benefit for the well-being and progress of the premature child until he leaves the hospital. This validated practice could be disseminated on a larger scale in other neonatal departments.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Risks and Benefits of Abdominal Massage Treatment in Neonatalogy in Premature Children
    Actual Study Start Date :
    Mar 15, 2018
    Anticipated Primary Completion Date :
    Oct 15, 2021
    Anticipated Study Completion Date :
    Oct 15, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Change in the neonatal infant pain score [up to 30 days from baseline]

      neonatal infant pain scale (EDIN)) (>4 or>=4)

    2. bradycardia [up to 30 days from baseline]

      bradycardia (yes/no)

    3. arterail oxygenation desaturation [up to 30 days from baseline]

      arterail oxygenation desaturation (yes/no)

    4. Change in the abdominal aspect [up to 30 days from baseline]

      bloating, visibility of the abdominal loops, collateral circulation, abdominal staining

    5. Significant adverse effects [up to 30 days from baseline]

      volvulus of the small intestine, intestinal perforation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children born before 37 weeks of amenorrhea hospitalized in the neonatology department
    Exclusion Criteria:
    • children with a malformation or a digestive pathology with or without surgery

    • medical prescription of non-massage care

    • children born under the secret

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Caen University Hospital Caen France 14033

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    • Principal Investigator: Virginie DELVAL, University Hospital, Caen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT03681782
    Other Study ID Numbers:
    • 17-015
    First Posted:
    Sep 24, 2018
    Last Update Posted:
    May 3, 2021
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Caen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2021