Effect of a small book on home care of preterm infants

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-2sk64p
• Date of registration: 21/05/2018
• Prospective Registration: Yes
• Primary sponsor: Escola de Enfermagem da Universidade de São Paulo
• Public title: Effect of a small book on home care of preterm infants
• Scientific title: Effect of an educational technology on the home stimulation of preterm infants: clinical, non-randomized trial
• Date of first enrolment: 01/06/2018
• Recruitment status: Not yet recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-2sk64p
• Study type: Intervention
• Study design: Pragmatic, parallel, two-arm, open-label, non-randomized clinical trial
• Phase: N/A

Countries of recruitment

Bahamas, Brazil

Contacts

• Name: Escola de Enfermagem da Universidade de São Paulo
• Affiliation: Escola de Enfermagem da Universidade de São Paulo

• Name: Escola de Enfermagem da Universidade de São Paulo
• Affiliation: Escola de Enfermagem da Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Family of children born with any level of prematurity who have been hospitalized in Neonatal Intensive Care Unit
Exclusion criteria: Non-resident family members in the municipality of São Paulo

Age minimum:
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

Other preterm newborns; Preterm Newborn

M01.060.703.520.520

P07.3

Intervention(s)

J01.897.280

Other

The researcher will offer during the preparation of the hospital discharge an educational technology called "History of Sofia", which is a small book; This material addresses aspects related to home stimuli that promote the development of children born prematurely for the families of the experimental group; When offering the educational material, the researcher will give a brief presentation of its content, in order to stimulate the interest of the family; Delivery prior to discharge is intended for family members to have time to handle and read the material in quieter conditions than those generally experienced on their way home;
The educational material will be offered to all families of preterm infants, regardless of whether you agree to participate in the research; It is estimated that 50 families will be formed to form the experimental group, and this training will begin after the necessary releases of the ethics committees and the Brazilian registry of clinical trials.
The control group will have as subjects the families of children born prematurely in the institution that were discharged prior to the date of release of the study by the ethics committees; Family members who will receive high-orientation counseling from the participating institution of this study and possibly will be following the guidelines offered for home care in the high-level plan of the institution and / or other guidelines indicated by the professionals who are accompanying the child's health;
A home visit will be carried out for each family of both groups with the purpose of measuring the home stimulus of both through the application of Infant-Toddler HOME instrument that is an instrument that measures within a naturalistic context the quality and quantity of stimulus available t

Primary Outcome(s)

Home care for infants born prematurely with higher quality and quantity of stimuli that promote child development, evaluated by the Infant-Toddler Observation Instrument for Measurement of the Inventory HOME, a sample was calculated so that a standardized difference is significant in a t-test for samples independent with 80% test power and significance level of 5%

Secondary Outcome(s)

Home care provided to preterm infants with higher quality and quantity of stimuli that promote child development, evaluated by the sub-scales of the Infant-Toddler Observation Instrument for Measurement of the HOME Inventory, a sample was calculated so that a standardized difference is significant in a t test for independent samples with 80% test power and significance level of 5%

Source(s) of Monetary Support

Hospital e Maternidade Rede D'OR São Luiz - Unidade Anália Franco

Escola de Enfermagem da Universidade de São Paulo

Secondary Sponsor(s)

Hospital e Maternidade Rede D'OR São Luiz - Unidade Anália Franco