Efecto De La Fisioterapia Respiratoria Sobre El Desarrollo De Niños/as Prematuros. Estudio Longitudinal.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 6
- 主要终点
- Assessment of change in motor development with Bayley III scale at 3, 6, 9 and 12 months of corrected age
研究概览
简要总结
The aim of this study is to investigate the effect of the stimulation of "reflex rolling" from the Vojta method and the effect of the expiratory flow increase technique on the development of the preterm infants. In the same way, it will be assessed whether the application of these techniques produce pain.
This application will be carried out in preterm infants of less than 32 weeks of gestation with neonatal respiratory distress syndrome (SDR) and carriers of mechanical ventilation. The intervention will take place in the neonatal intensive care unit (NICU) The intervention period is one month (4 weeks) and different follow-ups will be carried out at term age, at 3, 6, 9 and 12 months of corrected age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm Infants <32 gestational age
- •Admitted to the NICU
- •Hemodynamically stable
- •Stable convulsive pictures
- •Controlled thermoregulation
- •Mechanical ventilation (invasive or non-invasive)
- •Parents / guardians of legal age, with sufficient cognitive ability to understand consent
- •Signature of consent
排除标准
- •Periventricular leukomalacia
- •Grade III and IV intraventricular hemorrhage
- •Rib fracture
- •Asphyxia at birth
- •Necrotizing enterocolitis > or = II B
- •Abandoned Criteria:
- •Appearance of any of the complications mentioned above
- •Hospital transfer
- •Hospital discharge (if the intervention at home cannot be followed)
- •Voluntary decision of parents / guardians to abandon the study
- •Medical decision
结局指标
主要结局
Assessment of change in motor development with Bayley III scale at 3, 6, 9 and 12 months of corrected age
时间窗: at 3, 6, 9 and 12 months of corrected age.
The motor area of the Bayley III scale will be measured at 3, 6, 9 and 12 months of corrected age. The motor scale has two subscales, the gross motor scale and the fine motor scale. This motor scale is made up of 138 items (the gross motor scale is made up of 72 items and the fine motor scale of 66 items) through which it evaluates the degree of body control, coordination of large muscle masses and skill manipulative of hands and fingers.
次要结局
- Measurements related to lung function (SatO2)(The day of the initial and final evaluation (the day after finishing the intervention) in the three groups. In addition, they will be measured before and after each intervention in GE-I and GE-II during the month that the intervention lasts.)
- Measurements related to lung function (respiratory rate)(From date of randomization until 1 month)
- Days of mechanical ventilation.(From date of randomization until hospital discharge. This value will not be complete until the end of the intervention in all cases, an average of around 1 year)
- Numbers of hospital admissions for respiratory infection up to 12 months of corrected age(Assessment of 12 months of corrected age.)
- Motor activity of the premature infant measured through the Alberta Infant Motor Scale (AIMS) at term age, at 3, 6, 9 and 12 months of corrected age(at term age, at 3, 6, 9 and 12 months of corrected age.)
- Measurements related to lung function (FiO2)(From date of randomization until 1 month)
- Measurements related to lung function (PEEP and PIP)(From date of randomization until 1 month)
- Heart rate(From date of randomization until 1 month)
- Injury or respiratory failure(From date of randomization until 1 month)
- Hospitalization time(At hospital discharge.)
- Anthropometric measures(They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment after the intervention period, and at hospital discharge.)
- cephalic perimeter(They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.)
- Days of contribution of 02(From date of randomization until hospital discharge. This value will not be complete until the end of the intervention in all cases, an average of around 1 year)
- Pain during the intervention measured through the PIPP scale(Daily in all interventions, that is, every day that the intervention is applied during the month of the intervention period)
- Measurements related to lung function (PaO2 and PaCO2 or PvO2 and PvO2)(The measurement performed by the neonatal service will be recorded. It will be recorded in the first assessment, in the final assessment (the day after finishing the intervention) and daily during the month of the intervention period)
- Start time of autonomous feeding(At hospital discharge.)
- Weight(They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.)
- Height(They will be measured at the initial assessment (the day before the start of the intervention), at the final assessment (after the intervention period), and at hospital discharge.)
- Family and personal history(First day of participation in the study)
研究者
Ana Igual Blasco
Degree in Physiotherapy
Universidad de Murcia