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

Universidad de León143 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

143

Conditions

Massage Premature Infant Premature Birth Preterm Infant

Interventions

Protocol of massage therapy and kinesiotherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 26 WeeksMax age: 37 Weeks

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Effect on weight

Effect of treatment on weight

Time frame: From baseline to hospital discharge, approximately 10 days

Effect of lenght

Effect of treatment on lenght

Time frame: From baseline to hospital discharge, approximately 10 days

Effect on head circumference

Effect of treatment on head circumference

Time frame: From baseline to hospital discharge, approimately 10 days

Effect on neuromotor development

Effect 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).

Time frame: From baseline to up to 37 gestational weeks

Secondary Outcomes

Average daily weight gain

Effect of treatment on daily weight gain during the hospitalization period

Time frame: From baseline to hospital discharge, approimately 10 days

Data from ClinicalTrials.gov

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