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Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)

Assessment of the Efficacy of Massage and Kinesiotherapy Applied by the Parents on the Biological State, Neuromotor Activity and Other Associated Factors in Hospitalized Premature Birth (PreMas)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03704012
Acronym
PreMas
Enrollment
143
Registered
2018-10-12
Start date
2012-09-01
Completion date
2015-12-30
Last updated
2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Massage, Premature Birth, Premature Infant, Preterm Infant

Keywords

Premature Infant, Massage, Tactile Kinesthetic Stimulation

Brief summary

The purpose of this study was to analyze the efficacy of massage therapy and kinesiotherapy, applied by the parents of hospitalized preterm infants, in the improvement of the biological state, neuromotor activity and other associated factors.

Detailed description

Premature infants are prematurely deprived of the cutaneous stimulation provided during intrauterine development and of the continuous contact with their parents. It has and adverse effect on both psychological and biological development of the child. Knowledge of these factors has led many neonatal units to begin to introduce therapeutic massage protocols to facilitating satisfactory neuromotor and anthropometric development of preterm infants. In this study, premature newborns were assigned to one of two groups: A: Control Group. B: Massage and kinesiotherapy Group, 15 minutes twice a day.

Interventions

BEHAVIORALProtocol of massage therapy and kinesiotherapy

Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.

Sponsors

Universidad de León
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

The control group included all preterm infants from months 1-6 and 19-24 of the study. The intervention group included all the premature newborns from the 7-18 months of the study.

Eligibility

Sex/Gender
ALL
Age
26 Weeks to 37 Weeks
Healthy volunteers
No

Inclusion criteria

* Gestational age between 26 to 37 gestational weeks. * Low birth weight, less than 2249 grams. * Weight of at least 1250 grams at time of entry into study. * Must be at least 48 hours of age. * Must have hemodynamic stability. * Absence of congenital and genetic anomalies. * Absence of alterations of the central nervous system. * Intact skin. * Stable parameters (according to the neonatologist´s criteria) to participate in the intervention.

Exclusion criteria

* Family refusal to participate in the study. * High frequency mechanical ventilation. * Fraction of Inspired Oxygen (FiO2)\>70%. * Inotropic support. * Septic shock. * Persistent tachycardia. * Persistent bradycardia. * Gastrointestinal disorders.

Design outcomes

Primary

MeasureTime frameDescription
Effect on weightFrom baseline to hospital discharge, approximately 10 daysEffect of treatment on weight
Effect of lenghtFrom baseline to hospital discharge, approximately 10 daysEffect of treatment on lenght
Effect on head circumferenceFrom baseline to hospital discharge, approimately 10 daysEffect of treatment on head circumference
Effect on neuromotor developmentFrom baseline to up to 37 gestational weeksEffect of treatment on neuromotor development. Neuromotor development were measured using the Spanish Premie-Neuro Scale, a scale for the neurological examination of premature babies, between 23 and 37 gestational weeks. It consists of twenty-four items divided into three factors: Neurological, movement and responsiveness, each with eight items. Each of the items is assigned a score of 1, 3 or 5. The scores for items are added up to yield a total raw score, with the possible figures for this ranging from 24 to 120 (higher values represent a better neuromotor development).

Secondary

MeasureTime frameDescription
Average daily weight gainFrom baseline to hospital discharge, approimately 10 daysEffect of treatment on daily weight gain during the hospitalization period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026