Clinical trial NCT06759285: Effect of Cradle Position During Orogastric Tube Feeding on Comfort, Physiological Parameters and Vomiting
Official title: Effect of Cradle Position on Comfort, Physiological Parameters and Vomiting Frequency in Premature Neonates During Orogastric Tube Feeding: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Position Differences
Nutrition
Nursing Care
Keywords: Preterm
Nutrition
Cradle position
Comfort
Vital signs
vomiting
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 48
Sex: ALL
Minimum age (years): 32
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Newborn Information Form
timeFrame: First measurement:After admission in NICU 30th minutes
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: First feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: First feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
timeFrame: First feeding first measurement: 1 min before feeding
measure: Vomiting frequency tracking form
timeFrame: First feeding first measurement: 1 min before feeding
measure: Stool amount tracking form
timeFrame: First feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: First feeding first measurement: 1 min before feeding
measure: Abdominal Circumference Follow-up Form
timeFrame: First feeding first measurement: 1 min before feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: First feeding first measurement: 1 min before feeding
Secondary outcomes:
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: First feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: First feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
timeFrame: First feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: First feeding second measurement: 1 min after feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: First feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: First feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: First feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
timeFrame: First feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: First feeding third measurement: 15 min after feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: First feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: Second feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: Second feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
timeFrame: Second feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: Second feeding first measurement: 1 min before feeding
measure: Vomiting frequency tracking form
timeFrame: Second feeding first measurement: 1 min before feeding
measure: Stool amount tracking form
timeFrame: Second feeding first measurement: 1 min before feeding
measure: Abdominal Circumference Follow-up Form
timeFrame: Second feeding first measurement: 1 min before feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: Second feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: Second feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: Second feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
timeFrame: Second feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: Second feeding second measurement: 1 min after feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: Second feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: Second feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: Second feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
timeFrame: Second feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: Second feeding third measurement: 15 min after feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: Second feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: Third feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: Third feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
timeFrame: Third feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: Third feeding first measurement: 1 min before feeding
measure: Vomiting frequency tracking form
timeFrame: Third feeding first measurement: 1 min before feeding
measure: Stool amount tracking form
timeFrame: Third feeding first measurement: 1 min before feeding
measure: Abdominal Circumference Follow-up Form
timeFrame: Third feeding first measurement: 1 min before feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: Third feeding first measurement: 1 min before feeding
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: Third feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: Third feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
timeFrame: Third feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: Third feeding second measurement: 1 min after feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: Third feeding second measurement: 1 min after feeding
measure: Physiological Parameter Follow-up Form (Heart rate-min)
timeFrame: Third feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Respiration rate- min)
timeFrame: Third feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Oxygen saturation -SpO2%)
timeFrame: Third feeding third measurement: 15 min after feeding
measure: Physiological Parameter Follow-up Form (Body temperature- 0C)
timeFrame: Third feeding third measurement: 15 min after feeding
measure: Neonatal Comfort Behavior Scale
timeFrame: Third feeding third measurement: 15 min after feeding
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Sibel Küçükoğlu
state: Akademi Mahallesi
city: Konya
country: Turkey
facility: Sibel Kucukoglu
Study officials:
affiliation: Selcuk University
name: sibel küçükoğlu, Prof
role: STUDY_DIRECTOR
References: