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

Universidad de León

Status: Completed

Conditions: Massage; Preterm Infant; Premature Infant; Premature Birth

Treatments: Behavioral: Protocol of massage therapy and kinesiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03704012

PI12/02763

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 26 to 37 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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143 participants in 2 patient groups

Routine Care

No Intervention group

Description:

Control Group receives routine care.

Massage and kinesiotherapy

Experimental group

Description:

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

Treatment:

Behavioral: Protocol of massage therapy and kinesiotherapy