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

NCT03681782 | Terminated

• 1 other identifier: 17-015
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant

Keywords

premature infant, abdominal massage

Outcome Measures

Primary Outcomes (5)

• Change in the neonatal infant pain score

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

  up to 30 days from baseline

• bradycardia

  bradycardia (yes/no)

  up to 30 days from baseline

• arterail oxygenation desaturation

  arterail oxygenation desaturation (yes/no)

  up to 30 days from baseline

• Change in the abdominal aspect

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

  up to 30 days from baseline

• Significant adverse effects

  volvulus of the small intestine, intestinal perforation

  up to 30 days from baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children born before 37 weeks of amenorrhea hospitalized

You may qualify if:

• Children born before 37 weeks of amenorrhea hospitalized in the neonatology department

You may not qualify if:

• children with a malformation or a digestive pathology with or without surgery
• medical prescription of non-massage care
• children born under the secret

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Virginie DELVAL

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: September 24, 2018
• Study Start: March 15, 2018
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 30, 2023

Record last verified: 2022-02

Locations

FR (1)