ClinicalTrials.Veeva

Menu

Fidgety Movements in Cystic Fibrosis

H

Hacettepe University

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Other: Observational General Movements Assessments

Study type

Observational

Funder types

Other

Identifiers

NCT03381157
AkmerMutlu

Details and patient eligibility

About

Very low birth weight infants who are at risk for chronic lung diseases may also be at risk for brain anomalies such as increased echogenicity, leukomalacia and intracranial hemorrhage. Infants with bronchopulmonary dysplasia have been reported to have worse neurodevelopmental outcomes than healthy infants. It has also been pointed out that babies with prolonged and recurrent apneas during sleep may have weak General Movements (GMs) repertoire.

It has been mentioned that motor development retardation may also occur in neurodevelopmental diseases, genetic diseases and chronic lung diseases, as well as in cystic fibrosis. In infants with cystic fibrosis, motor development may be affected by increased incidence of hospitalization, previous infections, malnutrition, respiratory and digestive system disorders. There is no research done with GMs assessment to determine motor dysfunction in infants with cystic fibrosis and this topic is open to research.

Having more information about the motor development of babies by determining the motor characteristics and motor performance of infants with cystic fibrosis, it may be possible to start the disease-specific physiotherapy and rehabilitation programs as early as possible. For this reasons, in the study the investigators aimed to investigate the characteristics of GMs in the "Fidgety" period of 3-5 month term infants diagnosed with cystic fibrosis, to determine the motor performances and to investigate the relation between the GMs characteristics and the features of the disease.

The hypotheses the investigators have set for this study are listed below;

Ho: Spontaneous movements of the "Fidgety" period of infants diagnosed with 3-5 months of cystic fibrosis are not different from normal infants.

H1: Spontaneous movements of "Fidgety" period of infants diagnosed with cystic fibrosis between 3-5 months are different from normal infants.

Enrollment

38 patients

Sex

All

Ages

3 to 5 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Being diagnosed with cystic fibrosis
  • Being between the postterm 3rd and 5th months

Exclusion criteria

  • Having congenital anomalies,
  • Having an ongoing infection,
  • Risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (IVH / PVL), bronchopulmonary dysplasia,
  • Fidgety movements evaluation results; being abnormal (AF), sporadic (F +/-) or non-F (F-)
  • Baby's family does not want to be involved in the work

Trial design

38 participants in 2 patient groups

Cystic Fibrosis Group
Treatment:
Other: Observational General Movements Assessments
Control Group
Treatment:
Other: Observational General Movements Assessments

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems