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

Premature Infant Clinical Trial

— PREMASS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03681782
• Other study ID #: 17-015
• Status: Terminated
• Start date: March 15, 2018
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Infant

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

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