Clinical trial NCT03681782: Evaluation of the Risks and Benefits of Abdominal Massage Treatment in Neonatalogy in Premature Children
Official title: Evaluation of the Risks and Benefits of Abdominal Massage Treatment in Neonatalogy in Premature Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Premature Infant
Keywords: premature infant, abdominal massage
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born before 37 weeks of amenorrhea hospitalized

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the neonatal infant pain score
timeFrame: up to 30 days from baseline
measure: bradycardia
timeFrame: up to 30 days from baseline
measure: arterail oxygenation desaturation
timeFrame: up to 30 days from baseline
measure: Change in the abdominal aspect
timeFrame: up to 30 days from baseline
measure: Significant adverse effects
timeFrame: up to 30 days from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Virginie DELVAL
role: PRINCIPAL_INVESTIGATOR
References: