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Development, InfantNCT04689386

Effect of Chest Physiotherapy on the Development of Preterm Infants.

A study testing Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method and Group II (GE-II) - expiratory flow increase technique in people with Development, Infant and Respiratory Distress Syndrome in Premature Infant, run by Universidad de Murcia at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method and Group II (GE-II) - expiratory flow increase technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
3 sitesSpain
Study dates
26 Feb 2021to 31 Dec 2024
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Preterm Infants <32 gestational age
  • Admitted to the NICU
  • With SDR
  • Hemodynamically stable
  • Stable convulsive pictures
  • Controlled thermoregulation
Show all 9Show fewer
  • Mechanical ventilation (invasive or non-invasive)
  • Parents / guardians of legal age, with sufficient cognitive ability to understand consent
  • Signature of consent

Who cannot join

  • Periventricular leukomalacia
  • Grade III and IV intraventricular hemorrhage
  • Rib fracture
  • Asphyxia at birth
  • Necrotizing enterocolitis > or = II B
  • Abandoned Criteria:
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Universitario Torrecárdenas

    Almería, Almería, 04009

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital General Universitario de Elche

    Elche, Alicante, 03292

Other trials in Spain

About this study

Official title: Efecto De La Fisioterapia Respiratoria Sobre El Desarrollo De Niños/as Prematuros. Estudio Longitudinal.

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.

Being tested
Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method, Group II (GE-II) - expiratory flow increase technique
Keywords
Premature Infant, Respiratory Distress Syndrome, Chest Physiotherapy, Development
Medical subject headings
Premature Birth, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta methodOther

    This manoeuvre does not require the newborn to be moved, but only a slight rotation of the head towards the side from which the stimulus is delivered. The starting position for performing the first phase of reflex rolling is the asymmetric supine position, with the limbs freely lying on the resting surface.

    A digital pressure will exert on the chest area, where the mammillary line crosses the insertion of the diaphragm, either at the level of the 6th rib, or between the 5th and the 6th, or between the 6th and the 7th. A one minute stimulus will be performed on each side. The intervention will be repeated twice a day, ensuring that the period between one intervention and another is at least two hours.

  • Group II (GE-II) - expiratory flow increase techniqueOther

    The technique adapted to the premature infant will be performed. This maneuver consists of slowly applying light pressure to the infant's chest with one hand, obliquely, starting from the end of the inspiratory plateau until the end of expiration, which is prolonged. The hand should be placed between the sternal notch and the xiphoid process of the newborn's sternum. The therapist's other hand is placed on the last ribs (without applying pressure) as a bridge, of which the columns are the thumb and forefinger (or middle finger). Therefore, contact with the infant's abdomen is avoided and the expansion of the lower rib is limited, allowing a better displacement of the diaphragm and avoiding an increase in intra-abdominal pressure. The maneuver will be repeated three times, respecting the infant's responses and their physiological constants. The intervention will be repeated twice a day, trying to ensure that the period between one intervention and another is at least 2 hours.

Study groups in NCT04689386
Study groupRoleWhat they receive
Group I Stimulation of "reflex rolling" from the Vojta methodExperimentalNot described
Receives: Other: Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method
Group II Expiratory flow increase techniqueExperimentalNot described
Receives: Other: Group II (GE-II) - expiratory flow increase technique
Control GroupNo interventionRoutine intervention in the NICU with mechanical ventilation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of change in motor development with Bayley III scale at 3, 6, 9 and 12 months of corrected age

    The motor area of the Bayley III scale will be measured at 3, 6, 9 and 12 months of corrected age. The motor scale has two subscales, the gross motor scale and the fine motor scale. This motor scale is made up of 138 items (the gross motor scale is made up of 72 items and the fine motor scale of 66 items) through which it evaluates the degree of body control, coordination of large muscle masses and skill manipulative of hands and fingers.

    Measured: at 3, 6, 9 and 12 months of corrected age.

Secondary outcomes (19)

  1. 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

    Alberta Infant Motor Scale consists of 58 items based on descriptions of postural control in supine decubitus (9 items), prone decubitus (21 items), sitting (12 items) and standing (16 items). It is designed for children from 0 to 18 months.

    Measured: at term age, at 3, 6, 9 and 12 months of corrected age.

  2. Pain during the intervention measured through the PIPP scale

    The Premature Infant Pain Profile (PIPP) scale is based on mixed behavioral and physiological indicators. It has seven items and each item will be estimated from 0 to 3 to assess pain in premature infants.

    The maximum score is 21, and in term newborns it is 18. According to the score obtained, it is concluded:

    • Minimal pain or no pain: 0 to 6 points
    • Moderate pain: 7 to 12 points
    • Intense or severe pain: if it is greater than 12 points

    Measured: Daily in all interventions, that is, every day that the intervention is applied during the month of the intervention period

  3. Measurements related to lung function (PaO2 and PaCO2 or PvO2 and PvO2)

    Pa02 and PaCO2 or PvO2 and PvO2 will be assessed with an arterial blood gas / arterialized blood / venous blood gas from the measurement carried out by the neonatal service. It will be recorded in the first evaluation, in the final evaluation (the day after finishing the intervention) and daily during the intervention.

    Measured: 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

  4. Measurements related to lung function (SatO2)

    Sat02 and will be measured with the pulse oximeter.

    Measured: 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.

  5. Measurements related to lung function (respiratory rate)

    The values of respiratory rate will be those rebounded by mechanical ventilation or pulse oximeter.

    Measured: From date of randomization until 1 month

  6. Measurements related to lung function (FiO2)

    The values of FiO2 will be those rebounded by mechanical ventilation

    Measured: From date of randomization until 1 month

  7. Measurements related to lung function (PEEP and PIP)

    The values of PEEP and PIP will be those rebounded by mechanical ventilation

    Measured: From date of randomization until 1 month

  8. Heart rate

    Heart rate will be measured with the pulse oximeter.

    Measured: From date of randomization until 1 month

  9. Injury or respiratory failure

    Injury or respiratory failure will be calculated using the following formula: PaO2 / FiO2

    Measured: From date of randomization until 1 month

  10. Days of contribution of 02

    The days of contribution of 02 greater than 21% will be collected from the clinical history.

    Measured: 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

  11. Days of mechanical ventilation.

    The days of mechanical ventilation will be collected from the clinical history.

    Measured: 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

  12. Start time of autonomous feeding

    The age of the premature infant at the time of initiation of autonomous feeding will be collected from the clinical history.

    Measured: At hospital discharge.

  13. Hospitalization time

    The days of hospitalization will be collected from the clinical history.

    Measured: At hospital discharge.

  14. Anthropometric measures

    The weight measurement will be done through a scale or through the clinical history. Measurement of height and head circumference will be done with a tape measure or through the clinical history.

    Measured: 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.

  15. Weight

    The weight measurement will be done through a scale or through the clinical history.

    Measured: 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.

  16. Height

    Measurement of height will be done with a tape measure or through the clinical history.

    Measured: 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.

  17. cephalic perimeter

    Measurement cephalic perimeter will be done with a tape measure or through the clinical history.

    Measured: 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.

  18. Family and personal history

    A semi-structured interview will record the history of the pregnancy (type of fertilization: natural or artificial; parity: single, twin, multiple; type of delivery: eutocic, dystocic, etc.) and family data (type of family, age of the mother / father, educational level, socioeconomic level, etc.).

    Gestational age, gender, and APGAR score will be recorded from medical clinica.

    Measured: First day of participation in the study

  19. Numbers of hospital admissions for respiratory infection up to 12 months of corrected age

    The numbers of hospital admissions for respiratory infection up to 12 months of corrected age will be recorded through a questionnaire that will be delivered to the family.

    Measured: Assessment of 12 months of corrected age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2020
  2. Study start26 Feb 2021
  3. Primary completion6 Feb 2024
  4. Study completion31 Dec 2024

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04689386
Sponsor's protocol ID
74244433
Status last verified
Feb 2025
First submitted
2 Oct 2020
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abman SH, Bancalari E, Jobe A. The Evolution of Bronchopulmonary Dysplasia after 50 Years. Am J Respir Crit Care Med. 2017 Feb 15;195(4):421-424. doi: 10.1164/rccm.201611-2386ED. No abstract available.

    PubMed 28199157

  • Agerholm H, Rosthoj S, Ebbesen F. Developmental problems in very prematurely born children. Dan Med Bull. 2011 Jun;58(6):A4283.

    PubMed 21651878

  • Bancalari E, Jain D. Bronchopulmonary Dysplasia: 50 Years after the Original Description. Neonatology. 2019;115(4):384-391. doi: 10.1159/000497422. Epub 2019 Apr 11.

    PubMed 30974430

  • Baker CD, Abman SH. Impaired pulmonary vascular development in bronchopulmonary dysplasia. Neonatology. 2015;107(4):344-51. doi: 10.1159/000381129. Epub 2015 Jun 5.

    PubMed 26044102

  • Baker CD, Abman SH, Mourani PM. Pulmonary Hypertension in Preterm Infants with Bronchopulmonary Dysplasia. Pediatr Allergy Immunol Pulmonol. 2014 Mar 1;27(1):8-16. doi: 10.1089/ped.2013.0323.

    PubMed 24669351

  • Bayley, N. (2015). Escala Bayley de desarrollo infantil -III (Bayley-III). España: Person Educación

  • Camy LF, Mezzacappa MA. Expiratory flow increase technique and acid esophageal exposure in infants born preterm with bronchopulmonary dysplasia. Pediatr Phys Ther. 2011 Winter;23(4):328-33. doi: 10.1097/PEP.0b013e31823565c3.

    PubMed 22090070

  • Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences. 2nd. edit., Hillsdale, N.J., Erlbaum (Primera edición, 1977 New York: Academic Press)

  • Davidson J, Garcia KM, Yi LC, Goulart AL, Santos AM. Prevalence and factors associated with thoracic alterations in infants born prematurely. Rev Assoc Med Bras (1992). 2012 Nov-Dec;58(6):679-84.

    PubMed 23250096

  • Fernández Rego, F. J. y Gómez-Conesa, A. (2014). Importancia del tratamiento de Fisioterapia en el síndrome de dificultad respiratoria y en la displasia broncopulmonar. Fisioterapia, 245-246. https://doi.org/10.1016/j.ft.2014.09.004

  • Gasquez Góngora, JJ. (2010). Displasia broncopulmonar. Revista mexicana de Pediatría, 77(1), 27-31.

  • Giannantonio C, Papacci P, Ciarniello R, Tesfagabir MG, Purcaro V, Cota F, Semeraro CM, Romagnoli C. Chest physiotherapy in preterm infants with lung diseases. Ital J Pediatr. 2010 Sep 26;36:65. doi: 10.1186/1824-7288-36-65.

    PubMed 20868518

  • Gómez Conesa, A., Fernández-Rego, F.J., y Agueras Arenas, J.J. (2016). Vojta therapy in the reduction of perinatal risk in preterm infants with respiratory distress syndrome and bronchopulmonary dysplasia. Physiotherapy, 102, 199. DOI:https://doi.org/10.1016/j.physio.2016.10.242

  • Gonzáalvez Armengod, C., Omaña Alonso, MF. (2006). Protocolos de Neonatología: Síndrome de diestrés respiratorio neonatal o enfermedad de membrana hialina. Bol Pediatr, 46 (1), 160-165.

  • Hestnes J, Hoel H, Risa OJ, Romstol HO, Roksund O, Frisk B, Thorsen E, Halvorsen T, Clemm HH. Ventilatory Efficiency in Children and Adolescents Born Extremely Preterm. Front Physiol. 2017 Jul 13;8:499. doi: 10.3389/fphys.2017.00499. eCollection 2017.

    PubMed 28751866

Questions about this trial

What is this clinical trial studying?

A study testing Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method and Group II (GE-II) - expiratory flow increase technique in people with Development, Infant and Respiratory Distress Syndrome in Premature Infant, run by Universidad de Murcia at 3 sites in Spain.

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 11 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 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Assessment of change in motor development with Bayley III scale at 3, 6, 9 and 12 months of corrected age (time frame: at 3, 6, 9 and 12 months of corrected age.). 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 NCT04689386, which also lists 34 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 27 Mar 2025.

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