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Completed

NCT Number: NCT06648213

Individual Structured Therapy in Early Premature Infants at the Neonatal Intensive Care Unit

In this study, investigators aimed to apply an individual structured therapy protocol within the framework of neurodevelopmental therapy principles in early premature infants hospitalized in the neonatal intensive care unit and to examine its effect on the motor development of infants.

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Key information

Conditions

Infant Development Female Urogenital Diseases and Pregnancy Complications INDIVIDUALIZED THERAPY Neonatal Intensive Care Unit Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülhane Hospital

Ankara, Turkey (Türkiye)

About this study

The study is planned to include 20 early premature (<34 weeks) newborns hospitalised in the neonatal intensive care unit. The babies will be divided into two groups as therapy group and control group. Internet-based randomisation system will be used to determine the groups according to their risk levels. The risk levels will be determined according to the guidelines of the Turkish Neonatology Association.

Sterile gowns, masks and bonnets will be used during assessment and therapy to reduce the risk of infection in terms of the safety of the babies, and small lids will be opened so that the physiotherapist's hand can enter to maintain the temperature and oxygen balance in the incubator.

Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 37th week when vital signs are stable.

Control group: They will be monitored by performing routine care and positioning.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalised in the neonatal intensive care unit,
  • Born before 34 weeks of gestation
  • medium and low-risk babies
  • Newborns who were approved by their families to participate in the study Exclusion criteria
  • Diagnosed neurological, neuromuscular or genetic disease 2. Congenital anomalies 3. Newborns whose parents did not consent to participate in the study

Treatment and study plan

Physiotherapy

Other

Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 36th week when vital signs are stable.

Primary outcomes

  1. General Movements

    Time frame: For GMA analysis in our study, a 3-5 min video of the babies lying supine outside the incubator will be taken. The videos will be recorded at 34th week and 36th week.

    GMs movements are a complex set of movements involving the whole body of the baby, which start to be observed from the 9th week of intrauterine life, change shape after the second month of the postterm period and can be monitored until the 20th week in corrected form.

    GMA is a valid and reliable analysis used to determine brain dysfunctions in preterm, term and postterm infants up to the 20th week.

    GMA analysis can be performed during sleep or wakefulness in preterm infants.

  2. Hammersmith Neonatal Neurological Examination (HNNE)

    Time frame: The HNNE short form will be applied at 34th week and 36th week.

    HNNE is a rapid, practical and easy-to-apply assessment method. It can be used in the assessment of term and preterm babies of different ages within the neonatal period. It is one of the standard methods used to predict the risk of cerebral palsy.

Secondary outcomes

  1. Weigh

    Time frame: Three times a week between 34-36th weeks.

    Weight gain will be analyzed by recording daily weight.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Investigation of the Effect of Individual Structured Therapy Application on Motor Performance in Early Premature Infants Hospitalized in Neonatal Intensive Care Unit

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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