Effect of Cradle Position on Comfort, Physiological Parameters and Vomiting Frequency in Premature Neonates During Orogastric Tube Feeding: A Randomized Controlled Trial

Selcuk University3 个研究点分布在 1 个国家目标入组 48 人开始时间: 2024年1月15日最近更新: 2025年1月6日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Selcuk University
入组人数: 48
试验地点: 3
主要终点: Newborn Information Form

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study was planned to determine the effect of the cradle position applied during orogastric tube feeding in premature newborns on comfort, physiological parameters and vomiting frequency.

Hypotheses of the Study H1: The cradle position applied to premature newborns during orogastric tube feeding; H1a: It affects the comfort level compared to the control group. H1b: It affects physiological parameters compared to the control group. H1c: It affects the vomiting frequency compared to the control group.

详细描述

It is reported that the cradle position is the most preferred position by mothers during the breastfeeding process. The cradle position is a position where the mother holds the baby in her arms, the baby's head is placed on the inside of the mother's arm-elbow area, the baby's whole body is turned towards the mother, the baby's head is in line with the mother's breast, and the mother and the baby are in intense interaction. Although it is the most preferred position for breastfeeding, no study has been found in the literature evaluating the effect of the cradle position given during OGT feeding on the comfort level, physiological parameters and vomiting frequency of premature babies. For this reason, it is thought that it can be a supportive position that can be used by both neonatal nurses and mothers who are with their babies during the OGT feeding process for newborns preparing for the breastfeeding process in NICUs. It is thought that the study results will guide health workers and researchers regarding the supportive positions that should be given during newborn feeding.

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: Single (Participant)

盲法说明

In the study, since the researcher was a clinical nurse who fed the babies and also carried out the data collection process, researcher blinding could not be done. However, babies were considered blind by nature. The analysis of the study was carried out by an independent statistician, the data were coded as A and B by coding the groups in the SPSS program, and statistical blinding was performed by not sharing the groups represented by the letters with the statistician to prevent bias. The stages of the study were carried out under the guidance of the Consolidated Standards of Reporting Trials (CONSORT) guide.

入排标准

年龄范围: 32 Weeks 至 36 Weeks（Child）
性别: All
接受健康志愿者: 否

入选标准

•Having a feeding frequency of every 3 hours,
•Having a birth weight of 1000 grams and above,
•Having an indication for intermittent feeding (bolus) with OGT,
•Being placed in a bed,
•Not having a condition that prevents giving the cradle position (having undergone surgery, having a congenital anomaly, etc.)
•Having stable physiological parameters,
•Babies whose mothers were not with them during feeding (having undergone surgery, receiving inpatient treatment, being discharged and out of town, not wanting to be held during feeding, etc.) were included in the study.

排除标准

•• Continuous infusion, slow bolus feeding or parenteral nutrition method used for feeding,
•Switching to full oral feeding,
•Having nasal obstruction,
•Receiving oxygen therapy, mechanical ventilation/CPAP support during the study period,
•Receiving medication affecting gastrointestinal function during the study period (drugs that increase gastrointestinal tract motility and facilitate gastric emptying and gastrointestinal passage of nutrients, and drugs that decrease gastrointestinal tract motility).
•Any medical diagnosis determined other than prematurity (Congenital anomaly, metabolic disease, asphyxia, sepsis, hyperbilirubinemia, intracranial hemorrhage and gastrointestinal hemorrhage, anatomic gastrointestinal anomaly, gastrointestinal disease, infection, frequent vomiting, distension).

结局指标

主要结局

Newborn Information Form

时间窗: First measurement:After admission in NICU 30th minutes

This form was created by the researcher in accordance with the literature. The baby's gender, gestational week, birth weight, 1st and 5th APGAR Scores, postnatal day of study, corrected week, weight, amount of food and type of food were questioned.

Physiological Parameter Follow-up Form (Heart rate-min)