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

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

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.

Study Overview

• Status: Completed
• Conditions: Nutrition; Nursing Care; Position Differences
• Intervention / Treatment: Behavioral: Experimental (cradle position)

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42100
    • Sibel Küçükoğlu
  • Akademi Mahallesi
    • Selçuklu, Akademi Mahallesi, Turkey
      • Sibel Küçükoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Parameter Follow-up Form (Heart rate-min)	The heart rate was measured a second time immediately after feeding while the baby was in the cradle position in the nurse's arms.	First feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)	Respiration rate was measured a second time immediately after feeding while the baby was in the cradle position in the nurse's arms.	First feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)	Oxygen saturation was measured a second time immediately after feeding while the baby was in the cradle position in the nurse's arms.	First feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)	Body temperature was measured a second time immediately after feeding while the baby was in the cradle position in the nurse's arms.	First feeding second measurement: 1 min after feeding
Neonatal Comfort Behavior Scale	The second measurement was taken immediately after feeding with the baby in the cradle position.	First feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)	The heart rate was measured for the third time at 15 minutes after feeding, while the baby was in the nurse's arms in the cradle position.	First feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)	Respiration rate was measured for the third time at 15 minutes after feeding, while the baby was in the nurse's arms in the cradle position.	First feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)	Oxygen saturation was measured for the third time at 15 minutes after feeding, while the baby was in the nurse's arms in the cradle position.	First feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)	Body temperature was measured for the third time at 15 minutes after feeding, while the baby was in the nurse's arms in the cradle position.	First feeding third measurement: 15 min after feeding
Neonatal Comfort Behavior Scale	The third measurement was taken 15 minutes after feeding, with the baby in the cradle position on the nurse's lap.	First feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)	The heart rate was measured immediately before orogastric tube feeding after the baby was held in the cradle position.	Second feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Respiration rate- min)	Respiration rate was measured immediately before orogastric tube feeding after the baby was held in the cradle position.	Second feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)	Oxygen saturation was measured immediately before orogastric tube feeding after the baby was held in the cradle position.	Second feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)	Body temperature was measured immediately before orogastric tube feeding after the baby was held in the cradle position.	Second feeding first measurement: 1 min before feeding
Vomiting frequency tracking form	The frequency of the baby's vomiting was recorded.	Second feeding first measurement: 1 min before feeding
Stool amount tracking form	The baby's stool volume was recorded.	Second feeding first measurement: 1 min before feeding
Abdominal Circumference Follow-up Form	Abdominal circumference was measured while the baby was in bed, before the second feeding, and just before the nurse picked her/his up.	Second feeding first measurement: 1 min before feeding
Neonatal Comfort Behavior Scale	The measurement was taken after the baby was picked up and just before starting to feed.	Second feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Heart rate-min)	The heart rate was measured a second time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.	Second feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)	Respiration rate was measured a second time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.	Second feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)	Oxygen saturation was measured a second time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.	Second feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)	Body temperature was measured a second time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.	Second feeding second measurement: 1 min after feeding
Neonatal Comfort Behavior Scale	The second measurement was taken immediately after feeding with the baby in the cradle position in the second feeding.	Second feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)	The heart rate was measured third time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.	Second feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)	was measured third time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.	Second feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)	Respiration rate was measured third time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.	Second feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)	Body temperature was measured third time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.	Second feeding third measurement: 15 min after feeding
Neonatal Comfort Behavior Scale	The third measurement was taken immediately after feeding with the baby in the cradle position in the second feeding.	Second feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)	Heart rate was measured first time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Respiration rate- min)	Respiration rate was measured first time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)	Oxygen saturation was measured first time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)	Body temperature was measured first time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding first measurement: 1 min before feeding
Vomiting frequency tracking form	The frequency of the baby's vomiting was recorded.	Third feeding first measurement: 1 min before feeding
Stool amount tracking form	The baby's stool volume was recorded.	Third feeding first measurement: 1 min before feeding
Abdominal Circumference Follow-up Form	Abdominal circumference was measured while the baby was in bed, before the third feeding, and just before being picked up by the nurse.	Third feeding first measurement: 1 min before feeding
Neonatal Comfort Behavior Scale	The first measurement was taken immediately after the third feeding with the baby in the cradle position in the second feeding.	Third feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Heart rate-min)	Heart rate was measured second time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)	Respiration rate was measured second time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)	Oxygen saturation was measured second time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)	Body temperature was measured second time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding second measurement: 1 min after feeding
Neonatal Comfort Behavior Scale	The second measurement was taken immediately after the third feeding with the baby in the cradle position in the second feeding.	Third feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)	Heart rate was measured third time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)	was measured third time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Oxygen saturation -SpO2%)	Respiration rate was measured third time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)	Body temperature was measured third time immediately after third feeding while the baby was in the cradle position in the nurse's arms.	Third feeding third measurement: 15 min after feeding
Neonatal Comfort Behavior Scale	The third measurement was taken immediately after the third feeding with the baby in the cradle position in the second feeding.	Third feeding third measurement: 15 min after feeding

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Study Director: sibel küçükoğlu, Prof, Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition; vomiting; Preterm; Comfort; Vital signs; Cradle position
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: 2023/89

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No