跳至主要内容
临床试验/CTRI/2023/11/060341
CTRI/2023/11/060341已完成1 期

Influence of the Premature Infant Oral Motor Intervention (PIOMI) on Breastfeeding

Ferzeen Mody1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月5日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
scores on the Early Feeding Skills Assessment Scale

研究概览

简要总结

Preterm infants will be recruited from the Neonatal Intensive Care Unit (step down unit) after receiving referral for oromotor intervention or breastfeeding from the treating physician. Once referral is obtained the infant’s caregivers will be contacted and provided with the patient information sheet and consent form, along with a detailed explanation of the study. After consent is obtained from the primary caregiver, the infant will be recruited in the study. Randomization will not be attempted as it is a quasi experimental study and it is not feasible to randomize. Infants referred for oromotor stimulation will be part of the intervention group and the ones referred for breastfeeding will be part of the control group. The demographic data will be collected and pre intervention data (EFS) will be administered by the secondary investigator who will be blinded to reduce bias. The control group will receive standard care (breastfeeding support given by the nursing staff) and the intervention group will receive PIOMI (a structured intervention specifically designed for stable preterm infants developed by Brenda Lessen Knoll which includes cheek stretch, lip roll, lip curl, midblade tongue pressure, lateral tongue pressure, gum massage and non nutritive sucking) from the primary investigator. Infants in both groups may be breastfeeding as well as on formula feeds, however, the infant must be able to tolerate at least one breastfeeding trial in a day. Both groups will be assessed till they achieve 4 successful breastfeeding attempts in a day. The Early Feeding Skills Assessment Scale (EFS) will be administered every alternate day till the infant is able to breastfeed 4 times a day successfully. Once the infant can breastfeed 4 times a day, the intervention will then be stopped and the post intervention EFS score will be recorded by the secondary investigator for the intervention group. Once the infants in the control group achieve 4 direct breastfeeding attempts their EFS scores will be assessed and recorded as well. The outcomes measured will be, scores on the EFS and the days taken to achieve 1 and 4 successful direct breastfeeds. The pre-intervention and post-intervention EFS scores will tell us about the effectiveness of the intervention (PIOMI). This process may last from a few days to weeks depending on the infant’s response.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
32.00 Day(s) 至 40.00 Day(s)(—)
性别
All

入选标准

  • stable preterm infants, aged more than 32 weeks of gestation, referred for oromotor stimulation by the co-investigator (neonatologist), in the step down unit of the department of neonatology.

排除标准

  • preterm infants who have any congenital or genetic disorders which will not allow them to breastfeed in the near future; infants with necrotising enterocolitis, brain injury, cardiac complications or any illness; infants requiring assistive ventilation and infants receiving oxygen via high flow nasal cannula; mothers unable to breastfeed due to breast engorgement, poor milk flow, inverted nipple or any other complications.

结局指标

主要结局

scores on the Early Feeding Skills Assessment Scale

时间窗: baseline, day on which 1 direct breastfeed and 4 direct breastfeeds have been attained

次要结局

  • days taken to achieve 1 & 4 direct breastfeeding sessions, weight & age at which one & four successful direct breastfeeds were attained(baseline, days at which one & four successful direct breastfeeds are achieved)

研究者

发起方
Ferzeen Mody
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ferzeen Mody

Manipal College of Health Professions, MAHE, Manipal

研究点 (1)

Loading locations...

相似试验