Clinical trial NCT04689386: Effect of Chest Physiotherapy on the Development of Preterm Infants.
Official title: Efecto De La Fisioterapia Respiratoria Sobre El Desarrollo De Niños/as Prematuros. Estudio Longitudinal.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development, Infant
Respiratory Distress Syndrome in Premature Infant
Keywords: Premature Infant
Respiratory Distress Syndrome
Chest Physiotherapy
Development
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
Collaborators: name: Fundación para la Salud Infantil de la Comunidad Valenciana
First posted: 2020-12-30
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of the stimulation of "reflex rolling" from the Vojta method and the effect of the expiratory flow increase technique on the development of the preterm infants. In the same way, it will be assessed whether the application of these techniques produce pain.

This application will be carried out in preterm infants of less than 32 weeks of gestation with neonatal respiratory distress syndrome (SDR) and carriers of mechanical ventilation. The intervention will take place in the neonatal intensive care unit (NICU) The intervention period is one month (4 weeks) and different follow-ups will be carried out at term age, at 3, 6, 9 and 12 months of corrected age.


Eligibility criteria: Inclusion Criteria:

* Preterm Infants \<32 gestational age
* Admitted to the NICU
* With SDR
* Hemodynamically stable
* Stable convulsive pictures
* Controlled thermoregulation
* Mechanical ventilation (invasive or non-invasive)
* Parents / guardians of legal age, with sufficient cognitive ability to understand consent
* Signature of consent

Exclusion Criteria:

* Periventricular leukomalacia
* Grade III and IV intraventricular hemorrhage
* Rib fracture
* Asphyxia at birth
* Necrotizing enterocolitis \> or = II B

Abandoned Criteria:

* Appearance of any of the complications mentioned above
* Hospital transfer
* Hospital discharge (if the intervention at home cannot be followed)
* Voluntary decision of parents / guardians to abandon the study
* Medical decision

Primary outcomes:
measure: Assessment of change in motor development with Bayley III scale at 3, 6, 9 and 12 months of corrected age
timeFrame: at 3, 6, 9 and 12 months of corrected age.
Secondary outcomes:
measure: Motor activity of the premature infant measured through the Alberta Infant Motor Scale (AIMS) at term age, at 3, 6, 9 and 12 months of corrected age
timeFrame: at term age, at 3, 6, 9 and 12 months of corrected age.
measure: Pain during the intervention measured through the PIPP scale
timeFrame: Daily in all interventions, that is, every day that the intervention is applied during the month of the intervention period
measure: Measurements related to lung function (PaO2 and PaCO2 or PvO2 and PvO2)
timeFrame: The measurement performed by the neonatal service will be recorded. It will be recorded in the first assessment, in the final assessment (the day after finishing the intervention) and daily during the month of the intervention period
measure: Measurements related to lung function (SatO2)
timeFrame: The day of the initial and final evaluation (the day after finishing the intervention) in the three groups. In addition, they will be measured before and after each intervention in GE-I and GE-II during the month that the intervention lasts.
measure: Measurements related to lung function (respiratory rate)
timeFrame: From date of randomization until 1 month
measure: Measurements related to lung function (FiO2)
timeFrame: From date of randomization until 1 month
measure: Measurements related to lung function (PEEP and PIP)
timeFrame: From date of randomization until 1 month
measure: Heart rate
timeFrame: From date of randomization until 1 month
measure: Injury or respiratory failure
timeFrame: From date of randomization until 1 month
measure: Days of contribution of 02
timeFrame: From date of randomization until hospital discharge. This value will not be complete until the end of the intervention in all cases, an average of around 1 year
measure: Days of mechanical ventilation.
timeFrame: From date of randomization until hospital discharge. This value will not be complete until the end of the intervention in all cases, an average of around 1 year
measure: Start time of autonomous feeding
timeFrame: At hospital discharge.
measure: Hospitalization time
timeFrame: At hospital discharge.
measure: Anthropometric measures
timeFrame: They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment after the intervention period, and at hospital discharge.
measure: Weight
timeFrame: They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.
measure: Height
timeFrame: They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.
measure: cephalic perimeter
timeFrame: They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.
measure: Family and personal history
timeFrame: First day of participation in the study
measure: Numbers of hospital admissions for respiratory infection up to 12 months of corrected age
timeFrame: Assessment of 12 months of corrected age.
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas
Study officials:
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