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Effect of Chest Physiotherapy on the Development of Preterm Infants.

U

Universidad de Murcia

Status

Completed

Conditions

Respiratory Distress Syndrome in Premature Infant
Development, Infant

Treatments

Other: Group II (GE-II) - expiratory flow increase technique
Other: Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method

Study type

Interventional

Funder types

Other

Identifiers

NCT04689386
74244433

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

51 participants in 3 patient groups

Group I Stimulation of "reflex rolling" from the Vojta method
Experimental group
Treatment:
Other: Group I (GE-I) - Stimulation of "reflex rolling" from the Vojta method
Group II Expiratory flow increase technique
Experimental group
Treatment:
Other: Group II (GE-II) - expiratory flow increase technique
Control Group
No Intervention group
Description:
Routine intervention in the NICU with mechanical ventilation.

Trial contacts and locations

3

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Central trial contact

Ana Igual Blasco, Physiotherapist

Data sourced from clinicaltrials.gov

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