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

ConditionPrematurity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-2
SponsorFederal University of Health Science of Porto Alegre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

All those subjects who do not follow the items mentioned above;

Presenting neurological diseases;

Presence of acute diseases (eg pneumonia, bronchiolitis, trauma)

Musculoskeletal alterations;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Orientations for families

    Other intervention

    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.

  • Professional stimulation more orientations for families.

    Other intervention

    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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Premature that the family receives only orientation.Active comparator 1 intervention
Group B: Premature who receive intervention by a specialized professional more orientation for the familyActive comparator 1 intervention

Trial outcomes

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.

Time frame
24 months

Secondary outcomes

1

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

The AHEMD-IS is a validated and reliable instrument for the assessment of infants aged 3 to 18 months. The instrument consists of 35 items divided into 4 dimensions (Physical Space, Variety of Stimulation, Fine Motor Toys and Gross Motor Toys) and a total score that can be categorized into 4 descriptions of domestic motor affordances (scoring system): Insufficient, Moderately Adequate, Adequate and Excellent. The results suggest that this tool can be a useful tool to measure the quantity and quality of affordances in the home environment that favor children's motor development. Researchers will be able to use this instrument to explain this important contributor to children's motor development, as well as for evaluation and intervention recommendations, in addition to advising parents on household activities.

Time frame
24 months
2

Pediatric Baby Quality of Life Inventory (PedsQL@)

When considering that gains in quality of life in relation to an intervention process are desired outcomes from the perspective of favoring a good health condition, according to the BPS model of the ICF, the Pediatric Inventory on the quality of life of babies presents validity and reliability to be used both in healthy children and those with illnesses or atypical development. It presents versions according to age and health condition. For babies, it presents a version for 1-12 months and another for 13-24 months and is carried out by interviewing parents and/or caregivers. It allows the assessment of quality of life in relation to physical capacity, physical symptoms, emotional aspects, social interaction, cognition and a total score. In cases of specific health conditions or older children, there are specific forms.

Time frame
24 months
3

Socioeconomic Questionnaire for Brazil

The Socioeconomic Questionnaire for Brazil (ABEP) is a questionnaire used for socioeconomic definition. He reviews all items of appliances that are working, including those that are in storage, or if they are not working, but the family considers fixing or replacing them in 6 months. The points system is composed of the variables: Bathrooms, domestic servants, cars, microcomputer, dishwasher, refrigerator, freezer, washing machine, microwave, motorcycle, clothes dryer (scoring according to the quantity: 0, 1, 2 , 3, 4 or more). In addition, I evaluate the level of education of the head of the family: * Illiterate / Incomplete elementary school: 0 points * Complete Elementary I / Incomplete Elementary II: 1 point * Complete Elementary II / Incomplete High School: 2 points * Incomplete Middle School / Incomplete Higher Education: 4 points * Higher education: 7 points And this instrument also analyzes the conditions of public services for the items: piped

Time frame
24 months
4

Montreal Cognitive Assessment-MoCA

The MoCA (Montreal Cognitive Assessment) test will be used in this study as a tool for the cognitive assessment of parents, aiming to identify possible changes in cognitive functions, even if subtle. It is a validated and widely used tool in the screening of mild cognitive impairment, offering a comprehensive analysis of skills such as memory, attention, language, executive function and orientation. The application of the MoCA will allow a standardized and objective assessment of the cognitive performance of the participants, contributing to a better understanding of the cognitive profile of the parents in the study sample.

Time frame
24 months

Other outcomes

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