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Early stimulation in motor development of premature babies: randomized clinical trials

Effectiveness of early sensory-motor stimulation in neuropsychomotor development of premature newborns: randomized clinical trials

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-62prx9t
Enrollment
Unknown
Registered
2022-03-14
Start date
2021-09-27
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

Other preterm newborns

Interventions

After recruitment, 30 infants included will be divided into 2 groups, the intervention group (IG) and control group (CG). Randomization will be performed through opaque envelopes sealed and sequential
(2) midline head and hands orientation stimulus
(3) stimulation of postural control in the vertical position supported by the therapist
(4) stimulation of orientation of the head and hands in the midline in a vertical position
(5) stimulation of abdominal tonus (tapping), supported by the therapist performing anteroposterior movement of the trunk, in a vertical position
(6) stimulation of postural control in the prone position (inhibiting shoulder girdle retraction)
(7) relaxation and stretching of the cervical, shoulder girdle, and pelvic girdle muscles
(8) adequate positioning in the incubator, maintaining postural alignment and motor organization . The intervention will be performed once a day, during 10 minutes, from Monday to Friday, until 40 wee
E02.779

Sponsors

Universidade Estadual de Londrina
Lead Sponsor
Programa de Pós-Graduação em Ciências da Reabilitação - UEL/UNOPAR
Collaborator

Eligibility

Age
34 Weeks to 40 Weeks

Inclusion criteria

Inclusion criteria: Preterm infants born at less than 32 weeks of gestational age (GA) or weighing less than 1500g at birth for a period of one year will be recruited. To be included in the study, newborns (NBs) need to be hemodynamically stable (respiratory rate 40-60 rpm, heart rate 120-160 bpm, peripheral oxygen saturation above 91%) and with no signs of respiratory distress.

Exclusion criteria

Exclusion criteria: Those who are using invasive or non-invasive mechanical ventilation, who cannot participate in the intervention for up to 3 consecutive days, who have congenital malformations, genetic syndromes, postoperative period and grade VI intraventricular hemorrhage will be excluded.

Design outcomes

Primary

MeasureTime frame
Improvement in the evolution of motor development in the intervention group compared to the control group, assessed by statistically significant difference in the score on Hammersmith Neonatal Neurological Evaluation (HNNE) scale.

Secondary

MeasureTime frame
Increase or equivalence of weight gain in the intervention group compared to the control group.

Countries

Brazil

Contacts

Public ContactVanessa Probst

Programa de Pós-Graduação em Ciências da Reabilitação - UEL/UNOPAR

vanessaprobst@gmail.com+55(43)33712490

Outcome results

None listed

Source: REBEC (via WHO ICTRP)