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

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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