Clinical trial NCT03704012: Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (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
Overall status: COMPLETED
Phase: NA
Conditions: Massage
Premature Infant
Premature Birth
Preterm Infant
Keywords: Premature Infant
Massage
Tactile Kinesthetic Stimulation
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 143
Sex: ALL
Minimum age (years): 26
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effect on weight
timeFrame: From baseline to hospital discharge, approximately 10 days
measure: Effect of lenght
timeFrame: From baseline to hospital discharge, approximately 10 days
measure: Effect on head circumference
timeFrame: From baseline to hospital discharge, approimately 10 days
measure: Effect on neuromotor development
timeFrame: From baseline to up to 37 gestational weeks
Secondary outcomes:
measure: Average daily weight gain
timeFrame: From baseline to hospital discharge, approimately 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Proffesor. Nursing and Physical Therapy Department. University of León.
name: Daniel Fernández-García, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.