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

Premature Birth Clinical Trial

— PreMas  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704012
• Other study ID #: PI12/02763
• Status: Completed
• Phase: N/A
• Start date: September 1, 2012
• Est. completion date: December 30, 2015

Study information

• Verified date: October 2018
• Source: Universidad de León
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 30, 2015
• Est. primary completion date: January 2, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Massage
• Premature Birth
• Premature Infant
• Preterm Infant

Intervention

Behavioral:
• Protocol of massage therapy and kinesiotherapy
Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de León

References & Publications (2)

Álvarez MJ, Fernández D, Gómez-Salgado J, Rodríguez-González D, Rosón M, Lapeña S. The effects of massage therapy in hospitalized preterm neonates: A systematic review. Int J Nurs Stud. 2017 Apr;69:119-136. doi: 10.1016/j.ijnurstu.2017.02.009. Epub 2017 F — View Citation

Fernández D, Alvarez MJ, Rodríguez D, Rodríguez M, Fernández E, Urdiales P. Spanish Validation of the Premie-Neuro Scale in Premature Infants. J Pediatr Nurs. 2015 Jul-Aug;30(4):560-7. doi: 10.1016/j.pedn.2014.11.002. Epub 2014 Nov 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on weight	Effect of treatment on weight	From baseline to hospital discharge, approximately 10 days
Primary	Effect of lenght	Effect of treatment on lenght	From baseline to hospital discharge, approximately 10 days
Primary	Effect on head circumference	Effect of treatment on head circumference	From baseline to hospital discharge, approimately 10 days
Primary	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	Average daily weight gain	Effect of treatment on daily weight gain during the hospitalization period	From baseline to hospital discharge, approimately 10 days

External Links

•   Website of the research project funded by the Health Institute Carlos III, which aims to demonstrate how the application of massage and exercise therapy for parents enhance the biological, neurological and motor hospitalized premature infants