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

NCT06759285 | Completed

• 1 other identifier: 2023/89
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Position Differences; Nutrition; Nursing Care

Keywords

Preterm; Nutrition; Cradle position; Comfort; Vital signs; vomiting

Outcome Measures

Primary Outcomes (9)

• Newborn Information Form

  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.

  First measurement:After admission in NICU 30th minutes

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

  The heart rate was measured after the baby was picked up and placed in the cradle position, just before orogastric tube feeding.

  First feeding first measurement: 1 min before feeding

• Physiological Parameter Follow-up Form (Respiration rate- min)

  Respiration rate was measured after the baby was picked up and placed in the cradle position, just before orogastric tube feeding.

  First feeding first measurement: 1 min before feeding

• Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

  Oxygen saturation was measured after the baby was picked up and placed in the cradle position, just before orogastric tube feeding.

  First feeding first measurement: 1 min before feeding

• Vomiting frequency tracking form

  The frequency of the baby's vomiting was recorded.

  First feeding first measurement: 1 min before feeding

• Stool amount tracking form

  The baby's stool volume was recorded.

  First feeding first measurement: 1 min before feeding

• Physiological Parameter Follow-up Form (Body temperature- 0C)

  Body temperature was measured after the baby was picked up and placed in the cradle position, just before orogastric tube feeding.

  First feeding first measurement: 1 min before feeding

• Abdominal Circumference Follow-up Form

  Abdominal circumference was measured while the baby was in bed, before the first feeding, and just before the nurse picked her/his up.

  First feeding first measurement: 1 min before feeding

• Neonatal Comfort Behavior Scale

  The first measurement was taken after the baby was picked up and just before starting to feed.

  First feeding first measurement: 1 min before feeding

Secondary Outcomes (46)

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

  First feeding second measurement: 1 min after feeding

• Physiological Parameter Follow-up Form (Respiration rate- min)

  First feeding second measurement: 1 min after feeding

• Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)

  First feeding second measurement: 1 min after feeding

• Physiological Parameter Follow-up Form (Body temperature- 0C)

  First feeding second measurement: 1 min after feeding

• Neonatal Comfort Behavior Scale

  First feeding second measurement: 1 min after feeding

Study Arms (2)

Cradle position

EXPERIMENTAL

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.

Behavioral: Experimental (cradle position)

Control Group

NO INTERVENTION

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.

Interventions

Experimental (cradle position) 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).

Cradle position

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Sibel Küçükoğlu

Selçuklu, Akademi Mahallesi, Turkey (Türkiye)

Location

Sibel Kucukoglu

Konya, 42100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Vomiting

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• sibel küçükoğlu, Prof

  Selcuk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 6, 2025
• Study Start: January 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: December 10, 2024
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)