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Completed

NCT Number: NCT03704012

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protocol of massage therapy and kinesiotherapy

Behavioral

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

Other names: Massage, Massage Therapy, Tactile Kinesthetic Stimulation

Primary outcomes

  1. Effect on weight

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

    Effect of treatment on weight

  2. Effect of lenght

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

    Effect of treatment on lenght

  3. Effect on head circumference

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

    Effect of treatment on head circumference

  4. Effect on neuromotor development

    Time frame: 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 outcomes

  1. Average daily weight gain

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

    Effect of treatment on daily weight gain during the hospitalization period

Sponsors and collaborators

Lead sponsor

Universidad de León

Other

Registry information

Official study title

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)

Acronym: PreMas

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Oct 12, 2018
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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