Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
PreMas
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)
1 other identifier
interventional
143
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2012
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2015
CompletedFirst Submitted
Initial submission to the registry
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedOctober 12, 2018
October 1, 2018
4 months
February 23, 2018
October 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Average daily weight gain
From baseline to hospital discharge, approimately 10 days
Study Arms (2)
Routine Care
NO INTERVENTIONControl Group receives routine care.
Massage and kinesiotherapy
EXPERIMENTALIntervention Group, receives massage and kinesiotherapy. Behavioral: Protocol of massage therapy and kinesiotherapy. Infants received massage and kinesiotherapy twice a day; 15 minutes each.
Interventions
Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Alvarez MJ, Fernandez D, Gomez-Salgado J, Rodriguez-Gonzalez D, Roson M, Lapena 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 Feb 14.
PMID: 28235686RESULTFernandez D, Alvarez MJ, Rodriguez D, Rodriguez M, Fernandez 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.
PMID: 25433214RESULTAlvarez-Alvarez MJ, Fernandez-Garcia D, Gomez-Salgado J, Ordas B, Rodriguez-Gonzalez MD, Martinez-Isasi S. Effectiveness of the application of massage therapy and kinesitherapy by parents on premature neonates: A research protocol. J Adv Nurs. 2019 Nov;75(11):3097-3104. doi: 10.1111/jan.14135. Epub 2019 Jul 30.
PMID: 31236954DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Fernández-García, PhD
Proffesor. Nursing and Physical Therapy Department. University of León.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Collaborating Professor, Nursing and Physical Therapy Department, Universidad de León (Spain)
Study Record Dates
First Submitted
February 23, 2018
First Posted
October 12, 2018
Study Start
September 1, 2012
Primary Completion
January 2, 2013
Study Completion
December 30, 2015
Last Updated
October 12, 2018
Record last verified: 2018-10