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

Terminated

• Conditions: Premature Infant

• Registration Number: NCT03681782
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-16
• Study Start: 2018-03-15
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Status Verified: 2022-02
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the neonatal infant pain score	up to 30 days from baseline	neonatal infant pain scale (EDIN)) (\>4 or\>=4)
arterail oxygenation desaturation	up to 30 days from baseline	arterail oxygenation desaturation (yes/no)
bradycardia	up to 30 days from baseline	bradycardia (yes/no)
Significant adverse effects	up to 30 days from baseline	volvulus of the small intestine, intestinal perforation
Change in the abdominal aspect	up to 30 days from baseline	bloating, visibility of the abdominal loops, collateral circulation, abdominal staining

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France