MassagePreMasNCT03704012
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
A study testing Protocol of massage therapy and kinesiotherapy in people with Massage and Premature Infant, run by Universidad de León.
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. Read more about this study
- Who is it for?
- Ages 26 to 37 weeks
- Conditions the study is for
- Massage, Premature Infant, Premature Birth
- What is being tested?
- Protocol of massage therapy and kinesiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2012to 30 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- Absence of alterations of the central nervous system.
- Intact skin.
- Stable parameters (according to the neonatologist´s criteria) to participate in the intervention.
Who cannot join
- 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.
About this study
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)
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.
Read the 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.
- Conditions
- Massage, Premature Infant, Premature Birth, Preterm Infant
- Being tested
- Protocol of massage therapy and kinesiotherapy
- Keywords
- Premature Infant, Massage, Tactile Kinesthetic Stimulation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol of massage therapy and kinesiotherapyBehavioural
Also called Massage, Massage Therapy, Tactile Kinesthetic Stimulation
Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Control Group receives routine care. |
| Massage and kinesiotherapy | Experimental | Intervention Group, receives massage and kinesiotherapy. Behavioral: Protocol of massage therapy and kinesiotherapy. Infants received massage and kinesiotherapy twice a day; 15 minutes each. Receives: Behavioral: Protocol of massage therapy and kinesiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on weight
Effect of treatment on weight
Measured: From baseline to hospital discharge, approximately 10 days
Effect of lenght
Effect of treatment on lenght
Measured: From baseline to hospital discharge, approximately 10 days
Effect on head circumference
Effect of treatment on head circumference
Measured: 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).
Measured: From baseline to up to 37 gestational weeks
Secondary outcomes (1)
Average daily weight gain
Effect of treatment on daily weight gain during the hospitalization period
Measured: From baseline to hospital discharge, approimately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Sep 2012
- Primary completion2 Jan 2013
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MassageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María José Álvarez Álvarez, Universidad de León
- Investigators
- Daniel Fernández-García, PhD, Principal investigator, Proffesor. Nursing and Physical Therapy Department. University of León.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704012
- Sponsor's protocol ID
- PI12/02763
- Acronym
- PreMas
- Status last verified
- Oct 2018
- First submitted
- 23 Feb 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28235686Fernandez 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.
PubMed 25433214Alvarez-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.
PubMed 31236954
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03704012
- Acronym / sponsor ID
- PreMas / PI12/02763
- Conditions
- Massage, Premature Infant, Premature Birth, Preterm Infant
- Keywords
- Premature Infant, Massage, Tactile Kinesthetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 2 Jan 2013 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Control Group receives routine care. |
| Massage and kinesiotherapy | Experimental | Behavioral: Protocol of massage therapy and kinesiotherapyIntervention Group, receives massage and kinesiotherapy. Behavioral: Protocol of massage therapy and kinesiotherapy. Infants received massage and kinesiotherapy twice a day; 15 minutes each. |
Who may qualify
- Ages
- 26 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- Family refusal to participate in the study.
- High frequency mechanical ventilation.
- Fraction of Inspired Oxygen (FiO2)>70%.
- Inotropic support.
- Septic shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol of massage therapy and kinesiotherapyAlso: Massage, Massage Therapy, Tactile Kinesthetic StimulationInfants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each. | Behavioural | Massage and kinesiotherapy |
Primary outcome
Effect on weight
Time frame: From baseline to hospital discharge, approximately 10 days
Effect of treatment on weight
Effect of lenght
Time frame: From baseline to hospital discharge, approximately 10 days
Effect of treatment on lenght
Effect on head circumference
Time frame: From baseline to hospital discharge, approimately 10 days
Effect of treatment on head circumference
Effect on neuromotor development
Time frame: From baseline to up to 37 gestational weeks
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).
1 secondary outcome
Average daily weight gain
Time frame: From baseline to hospital discharge, approimately 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Results publication: PubMed 28235686Alvarez 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 publication: PubMed 25433214Fernandez 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.
- Derived from this study: PubMed 31236954Alvarez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Fernández-García, PhD principal investigator
Proffesor. Nursing and Physical Therapy Department. University of León.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol of massage therapy and kinesiotherapy in people with Massage and Premature Infant, run by Universidad de León.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on weight (time frame: From baseline to hospital discharge, approximately 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704012, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.