Effect of Cradle Position During Orogastric Tube Feeding on Comfort, Physiological Parameters and Vomiting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-12-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Position Differences Nutrition Nursing Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

According to the sample size calculation made with G power 3.1.9.7, it was determined that 42 newborns (Experiment = 21, Control = 21) would meet the required sample size (0.96 effect size, 0.85 power, 0.05 margin of error). It was planned to include 24 newborns in each group, considering that there may be data losses. Since it was stated in the studies that it could affect gastric residue, randomization was performed by stratifying the feeding method. In order to ensure equal distribution in terms of nutrition in each group, two layers were created as breast milk and formula milk. The block/permutation method, which is one of the randomized assignment methods, was also used in the study. With this method, blocks containing equal numbers of A and B, symbolizing the experimental and control groups, were created using permutation and these blocks were multiplied until the specified number of people were reached. www.random.org was used to select the A and B block combination.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Cradle position

The newborns in this group were swaddled and fed by being held in a cradle position on the nurse's lap during orogastric tube feeding.

Group Type EXPERIMENTAL

Experimental (cradle position)

Intervention Type BEHAVIORAL

The newborn in cot bed was swaddled freely with the help of a thin blanket during feeding. Then, the nurse, wearing a box apron, took the baby in her arms and gave it a cradle position. The baby's physiological parameters and Comfort Scale were filled in before feeding began. The baby was kept in a cradle position on the researcher's lap during feeding. Immediately after feeding, without changing the baby's position, the physiological parameters and Comfort Scale were evaluated a second time, and again 15 minutes after feeding, without changing the position, the physiological parameters and Comfort Scale were evaluated a third time and recorded. Then, the baby was gently and slowly laid down on the denim bed as usual (right lateral).

Control Group

The newborns in this group were fed with an orogastric tube, in the supine position on a flat bed, with the head elevated, as is routine practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental (cradle position)

The newborn in cot bed was swaddled freely with the help of a thin blanket during feeding. Then, the nurse, wearing a box apron, took the baby in her arms and gave it a cradle position. The baby's physiological parameters and Comfort Scale were filled in before feeding began. The baby was kept in a cradle position on the researcher's lap during feeding. Immediately after feeding, without changing the baby's position, the physiological parameters and Comfort Scale were evaluated a second time, and again 15 minutes after feeding, without changing the position, the physiological parameters and Comfort Scale were evaluated a third time and recorded. Then, the baby was gently and slowly laid down on the denim bed as usual (right lateral).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* • 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).

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No