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Completed

NCT Number: NCT06759285

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

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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Key information

Age range

32 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sibel Küçükoğlu, Selçuklu, Akademi Mahallesi, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. Newborn Information Form

    Time frame: 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.

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

    Time frame: First feeding first measurement: 1 min before feeding

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

  3. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: First feeding first measurement: 1 min before feeding

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

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

    Time frame: First feeding first measurement: 1 min before feeding

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

  5. Vomiting frequency tracking form

    Time frame: First feeding first measurement: 1 min before feeding

    The frequency of the baby's vomiting was recorded.

  6. Stool amount tracking form

    Time frame: First feeding first measurement: 1 min before feeding

    The baby's stool volume was recorded.

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

    Time frame: First feeding first measurement: 1 min before feeding

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

  8. Abdominal Circumference Follow-up Form

    Time frame: First feeding first measurement: 1 min before feeding

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

  9. Neonatal Comfort Behavior Scale

    Time frame: First feeding first measurement: 1 min before feeding

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

Secondary outcomes

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

    Time frame: First feeding second measurement: 1 min after feeding

    The heart rate was measured a second time immediately after feeding while the baby was in the cradle position in the nurse's arms.

  2. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: First feeding second measurement: 1 min after feeding

    Respiration rate was measured a second time immediately after feeding while the baby was in the cradle position in the nurse's arms.

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

    Time frame: First feeding second measurement: 1 min after feeding

    Oxygen saturation was measured a second time immediately after feeding while the baby was in the cradle position in the nurse's arms.

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

    Time frame: First feeding second measurement: 1 min after feeding

    Body temperature was measured a second time immediately after feeding while the baby was in the cradle position in the nurse's arms.

  5. Neonatal Comfort Behavior Scale

    Time frame: First feeding second measurement: 1 min after feeding

    The second measurement was taken immediately after feeding with the baby in the cradle position.

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

    Time frame: First feeding third measurement: 15 min after feeding

    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.

  7. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: First feeding third measurement: 15 min after feeding

    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.

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

    Time frame: First feeding third measurement: 15 min after feeding

    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.

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

    Time frame: First feeding third measurement: 15 min after feeding

    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.

  10. Neonatal Comfort Behavior Scale

    Time frame: First feeding third measurement: 15 min after feeding

    The third measurement was taken 15 minutes after feeding, with the baby in the cradle position on the nurse's lap.

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

    Time frame: Second feeding first measurement: 1 min before feeding

    The heart rate was measured immediately before orogastric tube feeding after the baby was held in the cradle position.

  12. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Second feeding first measurement: 1 min before feeding

    Respiration rate was measured immediately before orogastric tube feeding after the baby was held in the cradle position.

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

    Time frame: Second feeding first measurement: 1 min before feeding

    Oxygen saturation was measured immediately before orogastric tube feeding after the baby was held in the cradle position.

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

    Time frame: Second feeding first measurement: 1 min before feeding

    Body temperature was measured immediately before orogastric tube feeding after the baby was held in the cradle position.

  15. Vomiting frequency tracking form

    Time frame: Second feeding first measurement: 1 min before feeding

    The frequency of the baby's vomiting was recorded.

  16. Stool amount tracking form

    Time frame: Second feeding first measurement: 1 min before feeding

    The baby's stool volume was recorded.

  17. Abdominal Circumference Follow-up Form

    Time frame: Second feeding first measurement: 1 min before feeding

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

  18. Neonatal Comfort Behavior Scale

    Time frame: Second feeding first measurement: 1 min before feeding

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

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

    Time frame: Second feeding second measurement: 1 min after feeding

    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.

  20. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Second feeding second measurement: 1 min after feeding

    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.

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

    Time frame: Second feeding second measurement: 1 min after feeding

    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.

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

    Time frame: Second feeding second measurement: 1 min after feeding

    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.

  23. Neonatal Comfort Behavior Scale

    Time frame: Second feeding second measurement: 1 min after feeding

    The second measurement was taken immediately after feeding with the baby in the cradle position in the second feeding.

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

    Time frame: Second feeding third measurement: 15 min after feeding

    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.

  25. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Second feeding third measurement: 15 min after feeding

    was measured third time immediately after feeding in the second feeding while the baby was in the cradle position in the nurse's arms.

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

    Time frame: Second feeding third measurement: 15 min after feeding

    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.

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

    Time frame: Second feeding third measurement: 15 min after feeding

    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.

  28. Neonatal Comfort Behavior Scale

    Time frame: Second feeding third measurement: 15 min after feeding

    The third measurement was taken immediately after feeding with the baby in the cradle position in the second feeding.

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

    Time frame: Third feeding first measurement: 1 min before feeding

    Heart rate was measured first time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

  30. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Third feeding first measurement: 1 min before feeding

    Respiration rate was measured first time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

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

    Time frame: Third feeding first measurement: 1 min before feeding

    Oxygen saturation was measured first time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

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

    Time frame: Third feeding first measurement: 1 min before feeding

    Body temperature was measured first time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

  33. Vomiting frequency tracking form

    Time frame: Third feeding first measurement: 1 min before feeding

    The frequency of the baby's vomiting was recorded.

  34. Stool amount tracking form

    Time frame: Third feeding first measurement: 1 min before feeding

    The baby's stool volume was recorded.

  35. Abdominal Circumference Follow-up Form

    Time frame: Third feeding first measurement: 1 min before feeding

    Abdominal circumference was measured while the baby was in bed, before the third feeding, and just before being picked up by the nurse.

  36. Neonatal Comfort Behavior Scale

    Time frame: Third feeding first measurement: 1 min before feeding

    The first measurement was taken immediately after the third feeding with the baby in the cradle position in the second feeding.

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

    Time frame: Third feeding second measurement: 1 min after feeding

    Heart rate was measured second time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

  38. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Third feeding second measurement: 1 min after feeding

    Respiration rate was measured second time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

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

    Time frame: Third feeding second measurement: 1 min after feeding

    Oxygen saturation was measured second time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

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

    Time frame: Third feeding second measurement: 1 min after feeding

    Body temperature was measured second time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

  41. Neonatal Comfort Behavior Scale

    Time frame: Third feeding second measurement: 1 min after feeding

    The second measurement was taken immediately after the third feeding with the baby in the cradle position in the second feeding.

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

    Time frame: Third feeding third measurement: 15 min after feeding

    Heart rate was measured third time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

  43. Physiological Parameter Follow-up Form (Respiration rate- min)

    Time frame: Third feeding third measurement: 15 min after feeding

    was measured third time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

  44. Physiological Parameter Follow-up Form (Oxygen saturation -SpO2%)

    Time frame: Third feeding third measurement: 15 min after feeding

    Respiration rate was measured third time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

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

    Time frame: Third feeding third measurement: 15 min after feeding

    Body temperature was measured third time immediately after third feeding while the baby was in the cradle position in the nurse's arms.

  46. Neonatal Comfort Behavior Scale

    Time frame: Third feeding third measurement: 15 min after feeding

    The third measurement was taken immediately after the third feeding with the baby in the cradle position in the second feeding.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Acronym: CRADLE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

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