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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Massage, Premature Infant, Premature Birth, Preterm Infant

Intervention / Treatment
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* Behavioral: Protocol of massage therapy and kinesiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Care<br>Control Group receives routine care. | |
| Experimental: Massage and kinesiotherapy<br>Intervention Group, receives massage and kinesiotherapy. Behavioral: Protocol of massage therapy and kinesiotherapy. Infants received massage and kinesiotherapy twice a day; 15 minutes each. | Behavioral: Protocol of massage therapy and kinesiotherapy<br>* Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.<br>* Other names: Tactile Kinesthetic Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on weight | Effect of treatment on weight | From baseline to hospital discharge, approximately 10 days | 
| Effect of lenght | Effect of treatment on lenght | From baseline to hospital discharge, approximately 10 days | 
| Effect on head circumference | Effect of treatment on head circumference | 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). | From baseline to up to 37 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily weight gain | Effect of treatment on daily weight gain during the hospitalization period | From baseline to hospital discharge, approimately 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Infant, Massage, Tactile Kinesthetic Stimulation