Back to resultsEfficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) (PreMas)
Primary Purpose
Massage, Premature Infant, Premature Birth
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Protocol of massage therapy and kinesiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Massage focused on measuring Premature Infant, Massage, Tactile Kinesthetic Stimulation
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine Care
Massage and kinesiotherapy
Arm Description
Control Group receives routine care.
Intervention Group, receives massage and kinesiotherapy. Behavioral: Protocol of massage therapy and kinesiotherapy. Infants received massage and kinesiotherapy twice a day; 15 minutes each.
Outcomes
Primary Outcome Measures
Effect on weight
Effect of treatment on weight
Effect of lenght
Effect of treatment on lenght
Effect on head circumference
Effect of treatment on head circumference
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).
Secondary Outcome Measures
Average daily weight gain
Effect of treatment on daily weight gain during the hospitalization period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03704012
Brief Title
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2012 (Actual)
Primary Completion Date
January 2, 2013 (Actual)
Study Completion Date
December 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage, Premature Infant, Premature Birth, Preterm Infant
Keywords
Premature Infant, Massage, Tactile Kinesthetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The control group included all preterm infants from months 1-6 and 19-24 of the study. The intervention group included all the premature newborns from the 7-18 months of the study.
Masking
Investigator
Allocation
Non-Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Care
Arm Type
No Intervention
Arm Description
Control Group receives routine care.
Arm Title
Massage and kinesiotherapy
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Protocol of massage therapy and kinesiotherapy
Other Intervention Name(s)
Massage, Massage Therapy, Tactile Kinesthetic Stimulation
Intervention Description
Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.
Primary Outcome Measure Information:
Title
Effect on weight
Description
Effect of treatment on weight
Time Frame
From baseline to hospital discharge, approximately 10 days
Title
Effect of lenght
Description
Effect of treatment on lenght
Time Frame
From baseline to hospital discharge, approximately 10 days
Title
Effect on head circumference
Description
Effect of treatment on head circumference
Time Frame
From baseline to hospital discharge, approimately 10 days
Title
Effect on neuromotor development
Description
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).
Time Frame
From baseline to up to 37 gestational weeks
Secondary Outcome Measure Information:
Title
Average daily weight gain
Description
Effect of treatment on daily weight gain during the hospitalization period
Time Frame
From baseline to hospital discharge, approimately 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Fernández-García, PhD
Organizational Affiliation
Proffesor. Nursing and Physical Therapy Department. University of León.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28235686
Citation
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.
Results Reference
result
PubMed Identifier
25433214
Citation
Fernandez 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.
Results Reference
result
PubMed Identifier
31236954
Citation
Alvarez-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.
Results Reference
derived
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Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
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