Different Intervention Models of Premature Infants Based on the ICF Biopsychosocial Model

NCT05989438 | Recruiting

• 1 other identifier: PrematurityICF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Prematurity is an important risk factor for delayed neuropsychomotor development. The main objective of this study is to analyze the impact of different intervention models on the neuropsychomotor development of premature babies based on the ICF biopsychosocial model.

Conditions

Prematurity

Keywords

Prematurity; Physiotherapy; CIF; Child development; Early Intervention

Outcome Measures

Primary Outcomes (1)

• Bayley III

  The Bayley Scales of Infant and Child Development - 3rd Edition, consist of an instrument applied individually to assess the development of children between 1 and 42 months of age and are widely used in research and clinical practice to assess child development. They enable early diagnosis of developmental delays, providing information for planning and intervention. It can be used, for example, to evaluate children, typical, atypical, term or premature. The Bayley-III provides the examiner with the ability to adjust scores for prematurity up to 24 months, which is one of the most notable features of the scale. The adjustment corrects the child's age to his expected chronological age if he had been born at term. Currently in its third edition, Bayley III presents five distinct subtests for assessing child development in the areas of cognition, language, motor, socio-emotional and adaptive behavior.

  24 months

Secondary Outcomes (4)

• Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)

  24 months

• Pediatric Baby Quality of Life Inventory (PedsQL@)

  24 months

• Socioeconomic Questionnaire for Brazil

  24 months

• Montreal Cognitive Assessment-MoCA

  24 months

Study Arms (2)

Premature that the family receives only orientation.

ACTIVE COMPARATOR

The orientations will happen once a month via telephone, and once a week a reminder will be sent. Follow-up will occur from 4 to 12 corrected months.

Other: Orientations for families

Premature who receive intervention by a specialized professional more orientation for the family

ACTIVE COMPARATOR

The frequency of stimulation by a specialized professional will vary according to the degree of prematurity, from approximately 1 to 8 times per month. The guidelines will take place on the days of the calls. Follow-up will occur from 4 to 12 corrected months.

Other: Professional stimulation more orientations for families.

Interventions

Orientations for families OTHER

Guidance for parents will follow the guide/manual prepared by the researchers, in addition to verbal and video guidance. Once a week a reminder will be sent, and once a month researchers will contact you by phone for guidance. There will be 3 evaluations with an interval of 4 months. (4 months; 8 months; 12 months) and more one avaliation with an interval of 12 months at 24 months.

Premature that the family receives only orientation.

Professional stimulation more orientations for families. OTHER

Each session will last approximately 50 minutes, where the stimuli will be performed in: supine position; Ventral Decubitus; Seated; Four supports, kneeling/semi-kneeling and standing. If the child no longer uses the posture or it is not an acquisition for the age group in which the baby is, the time will be distributed in order to contemplate the expected acquisitions for the age group in which the baby is. The stimuli will be performed based on the neuropsychomotor development, in order of progression and according to the corrected age of the baby. The frequency of consultations may vary due to the different degrees of prematurity, and the stipulated initial frequency will vary between 1-8 times a month. The orientations will also be provided to family members during consultations, and families will also perform stimuli at home according to written, verbal and video guidance. There will be 3 evaluations with an interval of 4 months. (4 months; 8 months; 12 months).

Premature who receive intervention by a specialized professional more orientation for the family

Eligibility Criteria

• Age: 4 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Gestational age less than 37 weeks, corrected age between 4 and 12 months (one and a half month window) and at 24 months (four months window)
• Babies from the High Risk Outpatient Clinic of the UCS Clinical Center, registered there;
• Authorization of those responsible for the minor consenting to participation in the study by signing the Free and Informed Consent Form (TCLE).

You may not qualify if:

• All those subjects who do not follow the items mentioned above;
• Presenting neurological diseases;
• Presence of acute diseases (eg pneumonia, bronchiolitis, trauma)
• Musculoskeletal alterations;
• Genetic syndromes;
• In genetic investigation;
• Heart diseases with indication for surgical intervention;
• Untreated congenital torticollis;
• Congenital clubfoot;
• Cerebral hemorrhage grade IV
• Those who do not undergo the first and/or last evaluation;
• Incomplete evaluation;
• Convulsive crisis during study period;
• Participants from other intervention programs.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Fernanda Cechetti, Full professor

CONTACT

+ 55 51 998230-7733; fernandacec@ufcspa.edu.br

Tatiane Paludo, PhD Student

CONTACT

+ 55 54 99908-7992; tatiane.paludo@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PrematurityICF

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: January 11, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)