Skip to content

Effect of early intervention program for premature babies who were hospitalized in the Neonatal Intensive Care Unit

Effect of a family-centred intervention program on motor and cognitive development of preterm infant of Neonatal Intensive Care Unit: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6n4q8v
Enrollment
Unknown
Registered
2019-09-27
Start date
2018-04-11
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm infant. Child Development. Neonatal Intensive Care Units

Interventions

45 premature infants will participate in the study, which will be equally subdivided into three groups: 1) conventional intervention group
2) family-centered intervention group
and 3) Control group. During the intervention phase (12 weeks duration), the Conventional Intervention Group (GIC) will receive weekly physiotherapy sessions in a specialized clinic-school. The purpos
as well as during transitions. The intervention is individualized, and the physical therapist chooses the most appropriate exercises and modifies the manipulation for each child's level of development
The intervention will always include one or more activities in each position (OBERG et al .
2012). The intervention will always happen in inactive or active alert states, being interrupted in the presence of crying or sleep of the baby. It will occur at a frequency of 2x / week in the first
Other
E02.779

Sponsors

Universidade Metodista de Piracicaba
Lead Sponsor
Universidade Metodista de Piracicaba
Collaborator

Eligibility

Age
1 Weeks to 3 Weeks

Inclusion criteria

Inclusion criteria: Infants born preterm (IG below 37 weeks) who are admitted to the neonatal intensive care unit after birth, without congenital orthopedic or central nervous system malformations, and whose parents or guardians sign the Inform Consent forms. The babies should be evaluated after hospital discharge; not exceeding 3 weeks corrected age or 43 weeks postconceptional age

Exclusion criteria

Exclusion criteria: Infants who were born term or post-term (IG above 38 weeks) or preterm infants who were not hospitalized in the Neonatal Intensive Care Unit after birth with congenital orthopedic or central nervous system malformations will be considered as exclusion criteria for the study. whose parents or guardians do not sign the Informed Consent Form

Design outcomes

Primary

MeasureTime frame
As a primary outcome, the motor performance of the babies participants is expected to increase after the intervention period through the Test of Infant Motor Performance (TIMP) method and the Bayley Scales of Infant and Toddler Development-III (BSITD- III). It is expected to find an increase in the percentile and z-score of these scales, reaching values close to the expected normality for age.

Secondary

MeasureTime frame
As a secondary outcome, it is expected to find an increase in participants' cognitive performance assessed using the BSITD-III cognitive scale, and also to improve the motor and cognitive stimulation received in the family environment assessed by the AHEMD-IS instrument.

Countries

Brazil

Contacts

Public ContactDaniela Garbellini

Universidade Metodista de Piracicaba

daniela_garbellini@yahoo.com.br+5501931241515

Outcome results

None listed

Source: REBEC (via WHO ICTRP)