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

NCT ID: NCT05989438

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-01-11

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.

Detailed Description

Premature birth is defined as one in which it occurs before 37 completed weeks of gestation. Prematurity is due to different circumstances, and premature babies can be classified according to gestational age as extremely premature, very premature, or moderately to late preterm. Prematurity is one of the main biological risk factors, and that it contributes to the appearance of changes in the neuropsychomotor development of babies, which may compromise their functional capacity. Thus, screening is essential so that families are guided and premature babies receive adequate early intervention through follow-up programs, mainly aimed at functionality. Given this, and to help standardize health approaches, since 2001 with the development of the biopsychosocial model of health, based on the International Classification of Functioning, Disability and Health (ICF), the use of the ICF is recommended in research and in clinical practice. However, although the use of the ICF in interventions is recommended worldwide, and the literature shows a growing increase in the use of the ICF in studies involving children and young people, there is a shortage of studies, especially in what culminates neuropsychomotor development and prematurity. Thus, the main objective of this study is to analyze the impact of different interventional models on the neuropsychomotor development of premature babies based on the biopsychosocial model of the ICF. This is a randomized, uncontrolled clinical trial, participants will be premature babies with corrected age between 4 and 24 months. Parents of babies who meet the proposed inclusion criteria will be invited to allow participation by signing the Free and Informed Consent term.

The study is composed of two large groups: Stimulation plus Orientations Group and Orientations Group. Participants in both groups will follow the same inclusion and exclusion criteria. Regardless of delay in neuropsychomotor development, during and at the end of each of the three assessments, parents or guardians from both groups received verbal guidance. In addition, in the first evaluation, a printed guide with guidelines for stimulating the baby at home will be given to all families, where the guidelines were divided by months, encompassing from 4 to 24 corrected months.

The guidance guide for families was produced by the researchers emphasizing appropriate stimuli for the corrected age. The guide aims to stimulate neuropsychomotor development, in order to give the baby the opportunity to experiment with new skills, through different postures and transfers, and through facilitation, motor, cognitive, auditory, visual and sensory stimuli. The guidelines prioritize rudimentary postures (prone, supine, lateral decubitus, sitting and standing), in addition to stimuli on cognitive, language, visual and auditory aspects. Parents or guardians will be asked to stimulate their children daily, at the time that is most appropriate for the family's routine, strengthening the bond with the baby. Control of the frequency of performing the stimuli at home will be carried out, the control will be carried out by the families themselves by filling in a column in the guide for information on frequency. The researchers will get in touch with the families in the guidance group once a month to guide and clarify possible doubts, while the families in the guidance plus stimulation group, as they will attend more often than once a month, will have the opportunity to clarify doubts directly with the researcher during the consultations. The researchers will also be available to all families in both groups throughout the entire survey over the phone.

Thinking that we can find families with unfavorable socioeconomic conditions and, also, with the intention of standardizing the stimuli, appropriate toys for each age group will be delivered to all families in the two groups, which will be made by the researchers.

All babies in both groups will participate in a follow-up program where assessments will take place in 4 moments with an interval of 4 months between them on the first year of life (tolerating a window of one month and a half), where: initial assessment, time 1 (t1): 4 corrected months; time 2 (t2): 8 corrected months; time 3 (t3) 12 months corrected; on the time 4 (t4) (will be tolerating a window of four months), 24 months corrected for extreme birth babies (< 28 weeks gestational age) and 24 months cronologic for babies ≥ 28 weeks gestational age. There will be four moments of evaluation that will consist of the analysis of:

• Neuropsychomotor development through the Bayley Infant and Toddler Development Scales, third edition (Bayley III);
• Montreal Cognitive Assessment (MoCA).
• Patient identification data through an evaluation questionnaire and initial anamnesis, information from the health booklet and data from the medical record.
• Affordances in the Home Environment through Affordances in the Home Environment for Motor Development - Children's Scale (AHEMD-IS);
• Quality of life through the Pediatric Inventory on Baby Quality of Life (PedsQL®);
• Socioeconomic data through the Socioeconomic Questionnaire of the Brazilian Research Association (ABEP).
• Parents' cognitive assessment through the Montreal Cognitive Assessment (MoCA).

Conditions

Prematurity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Premature that the family receives only orientation.

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.

Group Type: ACTIVE_COMPARATOR

Orientations for families

Intervention Type: 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 who receive intervention by a specialized professional more orientation for the family

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.

Group Type: ACTIVE_COMPARATOR

Professional stimulation more orientations for families.

Intervention Type: 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).

Interventions

Orientations for families

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.

Intervention Type: OTHER

Professional stimulation more orientations for families.

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1. 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Cechetti

PrematurityICF

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fernanda Cechetti, Full professor

Role: CONTACT

fernandacec@ufcspa.edu.br

+ 55 51 998230-7733

Tatiane Paludo, PhD Student

Role: CONTACT

tatiane.paludo@yahoo.com.br

+ 55 54 99908-7992

Other Identifiers

PrematurityICF

Identifier Type: -

Identifier Source: org_study_id