Tummy time intervention in the neuromotor development of preterm newborns - randomized clinical trial
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
The aim of the study is to evaluate the effects of the Tummy Time practice on head control in moderate to late preterm infants. This is a randomized, controlled clinical trial with PTNBs below 2500g, who will be followed up from birth to 6 months of corrected age. The sample will consist of 42 preterm infants who will be randomized into a control group (n=21) and an experimental group (n=21), when they are discharged to the follow-up clinic. Both will be monitored by the outpatient team, however the PTNB randomized to the experimental group will also be instructed to perform the Tummy Time for 30 minutes daily, which can be distributed throughout the day. An illustrative booklet will also be offered as support material for this group. The control group will receive guidance routinely offered by the care team of the follow-up outpatient clinic. In addition, the study will also assess the effects of practice on the development of gross motor function, vertical alignment and horizontal leveling of the head, and palm grip strength. Data will be analyzed by inferential analysis and hypothesis testing, considering an alpha equal to 5% to differentiate between groups. It is expected that the Tummy time practice in PTNBs will strengthen the cervical muscles necessary to overcome the force of gravity and master motor skills early and allow the integration between family protagonism and environmental experiences that allow the organization between the nervous and musculoskeletal systems. skeletal face to the demands of the tasks exposed to the baby.
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 0 至 4M（—）
入选标准
- •Participants will be selected according to the following criteria: (1) neonates born between 30 wk and 36 wk and 6 days, according to ultrasound; (2) adequate for gestational age; (3) Apgar = 7 in the 5th minute; (4) birth weight less than 2500 g; (5) intrauterine growth restriction (6) absence of cardiorespiratory complications such as bronchopulmonary dysplasia and congenital heart diseases, neurological such as brain malformation, microcephaly, hydrocephalus, musculoskeletal disorders such as congenital clubfoot and congenital muscular torticollis, or auditory according to the little ear test; genetic syndromes, congenital infections (toxoplasmosis, syphilis, rubella, cytomegalovirus and herpes simplex) and visual changes according to the little eye test; (7) present poor or normal motor repertoire in the assessment of Generalized Movements (MG).
排除标准
- •The following will be excluded: (1) babies diagnosed with grade III and IV intraventricular hemorrhage; (2) babies whose parents withdraw from participating (3) babies who do not attend 2 assessments to monitor primary and secondary outcomes, (4) parents do not answer the phone for 3 consecutive days to reschedule assessments or declare withdrawal from the intervention by of the guardians, (5) parents who do not fill out the field diary to monitor the practice of Tummy Time. After randomization, participants will be excluded if they present any health deterioration and need to be hospitalized, change state and/or country.