Position DifferencesCRADLENCT06759285
Effect of Cradle Position During Orogastric Tube Feeding on Comfort, Physiological Parameters and Vomiting
A study testing Experimental (cradle position) in people with Position Differences and Nutrition, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 36 weeks
- Conditions the study is for
- Position Differences, Nutrition, Nursing Care
- What is being tested?
- Experimental (cradle position)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- • 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).
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sibel Kucukoglu
Konya, 42100
Sibel Küçükoğlu
Selçuklu, Akademi Mahallesi
About this study
Official title: 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.
Read the 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.
- Conditions
- Position Differences, Nutrition, Nursing Care
- Being tested
- Experimental (cradle position)
- Keywords
- Preterm, Nutrition, Cradle position, Comfort, Vital signs, vomiting
- Medical subject headings
- Premature Birth, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (cradle position)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First feeding first measurement: 1 min before feeding
Vomiting frequency tracking form
The frequency of the baby's vomiting was recorded.
Measured: First feeding first measurement: 1 min before feeding
Stool amount tracking form
The baby's stool volume was recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First feeding first measurement: 1 min before feeding
Secondary outcomes (46)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Second feeding first measurement: 1 min before feeding
Vomiting frequency tracking form
The frequency of the baby's vomiting was recorded.
Measured: Second feeding first measurement: 1 min before feeding
Stool amount tracking form
The baby's stool volume was recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Third feeding first measurement: 1 min before feeding
Vomiting frequency tracking form
The frequency of the baby's vomiting was recorded.
Measured: Third feeding first measurement: 1 min before feeding
Stool amount tracking form
The baby's stool volume was recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Third feeding third measurement: 15 min after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start15 Jan 2024
- Primary completion15 Sep 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Position DifferencesStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- sibel küçükoğlu, Prof, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759285
- Sponsor's protocol ID
- 2023/89
- Acronym
- CRADLE
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cradle Position on Comfort, Physiological Parameters and Vomiting Frequency in Premature Neonates During Orogastric Tube Feeding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06759285
- Acronym / sponsor ID
- CRADLE / 2023/89
- Conditions
- Position Differences, Nutrition, Nursing Care
- Keywords
- Preterm, Nutrition, Cradle position, Comfort, Vital signs, vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cradle position | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.)
Key exclusion criteria (6 listed)
- • Continuous infusion, slow bolus feeding or parenteral nutrition method used for feeding,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Cradle position |
Primary outcome
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.
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.
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.
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.
Vomiting frequency tracking form
Time frame: First feeding first measurement: 1 min before feeding
The frequency of the baby's vomiting was recorded.
Stool amount tracking form
Time frame: First feeding first measurement: 1 min before feeding
The baby's stool volume was recorded.
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.
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.
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.
46 secondary outcomes
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: First feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: First feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: First feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)
Time frame: First feeding second measurement: 1 min after feeding
Neonatal Comfort Behavior Scale
Time frame: First feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: First feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: First feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: First feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)
Time frame: First feeding third measurement: 15 min after feeding
Neonatal Comfort Behavior Scale
Time frame: First feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Second feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Second feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Second feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)
Time frame: Second feeding first measurement: 1 min before feeding
Vomiting frequency tracking form
Time frame: Second feeding first measurement: 1 min before feeding
Stool amount tracking form
Time frame: Second feeding first measurement: 1 min before feeding
Abdominal Circumference Follow-up Form
Time frame: Second feeding first measurement: 1 min before feeding
Neonatal Comfort Behavior Scale
Time frame: Second feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Second feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Second feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Second feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)
Time frame: Second feeding second measurement: 1 min after feeding
Neonatal Comfort Behavior Scale
Time frame: Second feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Second feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Second feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Second feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)
Time frame: Second feeding third measurement: 15 min after feeding
Neonatal Comfort Behavior Scale
Time frame: Second feeding third measurement: 15 min after feeding
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Third feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Third feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Third feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)
Time frame: Third feeding first measurement: 1 min before feeding
Vomiting frequency tracking form
Time frame: Third feeding first measurement: 1 min before feeding
Stool amount tracking form
Time frame: Third feeding first measurement: 1 min before feeding
Abdominal Circumference Follow-up Form
Time frame: Third feeding first measurement: 1 min before feeding
Neonatal Comfort Behavior Scale
Time frame: Third feeding first measurement: 1 min before feeding
Physiological Parameter Follow-up Form (Heart rate-min)
Time frame: Third feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Respiration rate- min)
Time frame: Third feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (oxygen saturation -SpO2%)
Time frame: Third feeding second measurement: 1 min after feeding
Physiological Parameter Follow-up Form (Body temperature- 0C)
Time frame: Third feeding second measurement: 1 min after feeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sibel küçükoğlu, Prof study director
Selcuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (cradle position) in people with Position Differences and Nutrition, run by Selcuk University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Information Form (time frame: First measurement:After admission in NICU 30th minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.