Faculty Member at Hasan Kalyoncu University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Baby's sucking power
研究概览
简要总结
ABSTRACT Objective: To test the effect of the Premature Infant Oral Motor Intervention (PIOMI) at 29-30 weeks post-menstrual age on the development of oral-motor function and sucking capacity.
Study Design: This study was a single-blind randomized controlled experimental design. The sample consisted of 60 preterm babies from two Neonatal Intensive Care Units in Gaziantep, Turkey between May 2019 and March 2020, with 30 each in the control and experimental groups. The PIOMI was applied to the experimental group for five minutes a day for 14 consecutive days. Sucking capacity, growth, feeding outcomes, and length of hospital stay (LOS) were measured. The Yakut Manometer Measuring Suction Power (PCT/TR2019/050678) was developed specifically for this study and tested for the first time.
详细描述
METHODS The data were obtained for 11 months between May 2019 and March 2020 in the NICUs of two different hospitals in the Gaziantep province of Turkey using a single-blind randomized controlled experimental design.
Eligibilty was determined by the neonatologist based on the following inclusion criteria: 1) babies born at 26-30 weeks PMA, 2) stable clinical condition, 3) vital signs stable for at least 24 hours, 4) able to have PIOMI by the 29th or 30th week PMA, 5) required respiratory support limited to an oxyhood, Continuous Positive Airway Pressure (CPAP) and/or nasal cannula up to 2L flow, 6) APGAR scores at 1- and 5-minutes of 4 and above, 7) any race or ethnicity, 8) intraventricular hemmorhage limited to level 1 or 2; and 9) had no birth defects including facial anomolies that would impact feeding.
Sample The sample consisted of a total of 60 preterm infants all born after 26 weeks PMA with 30 each in the experimental and control group. Subjects were enrolled when they reached 29 or 30 weeks PMA and met inclusion criteria, and whose parents gave written consent.
Random assignment to groups was performed by a research assistant, who was not involved in the research but worked in the same unit as the researchers, using the online software at https://www.randomizer.org. The primary nurses were blinded to groups, and the parents stepped out during therapy to assist in blinding.
Two subjects were lost during the research period. Subject number 15 in the experimental group died on the 11th day after enrollment of causes unrelated to the intervention. Subject number 31 in the control group was intubated on the 7th day after enrollment thus became ineligable. After a subject dropped out, the next subject enrolled replaced that subject and the study was continued with the same sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The PIOMI was applied only by the trained researcher, and blind to the nursing staff in charge of care and feeding. No information about the PIOMI was shared with the general staff working in the NICU, and it was performed in the absence of the mothers, although no formal curtain was used for additional blinding.
入排标准
- 年龄范围
- 29 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibilty was determined by the neonatologist based on the following inclusion criteria:
- •babies born at 26-30 weeks PMA,
- •stable clinical condition,
- •vital signs stable for at least 24 hours,
- •able to have PIOMI by the 29th or 30th week PMA,
- •required respiratory support limited to an oxyhood, Continuous Positive Airway Pressure (CPAP) and/or nasal cannula up to 2L flow,
- •APGAR scores at 1- and 5-minutes of 4 and above,
- •any race or ethnicity,
- •intraventricular hemmorhage limited to level 1 or 2; and
- •had no birth defects including facial anomolies that would impact feeding.
排除标准
- •Whose gestational age at birth was less than 26 weeks,
- •had congenital disorder or birth trauma,
- •were diagnosed with severe asphyxia,
- •had intraventricular bleeding,
- •had Newborn Withdrawal Syndrome,
- •had Fetal Alcohol Syndrome,
- •were receiving ventilator support,
- •were receiving Extracorporeal Membrane Oxygenation,
- •developed any complications during the follow-up period in the intervention group, whose balance status deteriorated,
- •whose written and verbal permissions were obtained from their parents.
结局指标
主要结局
Baby's sucking power
时间窗: The sucking power of the baby included in the study was measured up to 32 weeks.
The suction power of the baby was measured in mmHg with the Manometer measuring the Sucking Power.
Baby's sucking amount
时间窗: The sucking amount of the baby included in the study was measured up to 32 weeks.
The baby's sucking amount was calculated in milliliters.
Baby's sucking before releasing the bottle
时间窗: The sucking time without leaving the bottle of the baby included in the study was measured up to 32 weeks.
The baby's sucking time without leaving the bottle was calculated in seconds.
Baby's total sucking time
时间窗: The total sucking time of the baby included in the study was measured up to 32 weeks.
The baby's total sucking time was calculated in seconds.
次要结局
- Baby's head circumference(Baby's head circumference was measured for up to 40 weeks.)
- Baby's height(Baby's height was measured for up to 40 weeks.)
- Discharge time(Up to 40 weeks were measured on the day of discharge.)
- Baby's body weight(The baby's body weight was measured for up to 40 weeks.)
- First day of oral feeding time(The day when the baby was able to have the first oral feeding was measured up to 40 weeks.)
研究者
Selver Güler
Dr. Asst.Prof.
Hasan Kalyoncu University