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

Not Applicable

Completed

• Conditions: Massage; Premature Birth; Preterm Infant; Premature Infant
• Interventions: Behavioral: Protocol of massage therapy and kinesiotherapy

• Registration Number: NCT03704012
• Lead Sponsor: Universidad de León

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.

Study Timeline

• Study Start: 2012-09-01
• Primary Completion: 2013-01-02
• Study Completion: 2015-12-30
• Study First Submitted: 2018-02-23
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-03
• Last Update Submitted: 2018-10-03
• Study First Posted: 2018-10-12
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Massage and kinesiotherapy	Protocol of massage therapy and kinesiotherapy	Intervention Group, receives massage and kinesiotherapy. Behavioral: Protocol of massage therapy and kinesiotherapy. Infants received massage and kinesiotherapy twice a day; 15 minutes each.

Primary Outcome Measures

Name	Time	Method
Effect of lenght	From baseline to hospital discharge, approximately 10 days	Effect of treatment on lenght
Effect on head circumference	From baseline to hospital discharge, approimately 10 days	Effect of treatment on head circumference
Effect on weight	From baseline to hospital discharge, approximately 10 days	Effect of treatment on weight
Effect on neuromotor development	From baseline to up to 37 gestational weeks	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).

Secondary Outcome Measures

Name	Time	Method
Average daily weight gain	From baseline to hospital discharge, approimately 10 days	Effect of treatment on daily weight gain during the hospitalization period