PrematurityOGpretermNCT06222047
Pain and Comfort Level During Orogastric Catheter Insertion in Preterms
A study testing breast milk and dextrose in people with Prematurity and Pain Acute, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the research: This research was planned to evaluate the effect of breast milk and dextrose application, which are pain relief methods, on the pain and comfort levels of preterm babies who will have an orogastric tube inserted in the 3rd and 4th levels of the Neonatal Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 32 to 34 weeks
- Conditions the study is for
- Prematurity, Pain Acute, Comfort
- What is being tested?
- breast milk and dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Dec 2023
- 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 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth week 32-34,
- Postnatal week has reached 32-34 weeks,
- Birth weight over 1500 grams,
- whose general condition is stable,
- Planned to insert an orogastric tube,
- Developed sucking and swallowing reflexes, being able to hold a pacifier,
- Having breast milk,
- Preterms whose parents agreed to participate in the study were included in the study.
Who cannot join
- In need of oxygen support,
- Receiving analgesic and/or sedation treatment,
- In the preoperative and/or postoperative period,
- Those with congenital anomalies of the mouth and palate,
- Those with metabolic (e.g. NEC) and genetic (e.g. osteogenesis imperfecta) diseases,
- Painful intervention was performed at least 30 minutes before the procedure, Preterm babies will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breast Milk and Dextrose on the Orogastric Tube Insertion-related Pain and Comfort Levels of Preterm Babies
Purpose of the research:
This research was planned to evaluate the effect of breast milk and dextrose application, which are pain relief methods, on the pain and comfort levels of preterm babies who will have an orogastric tube inserted in the 3rd and 4th levels of the Neonatal Intensive Care Unit.
Read more
Hypotheses:
H0: The methods used during orogastric tube insertion do not affect the pain and comfort levels of preterm babies.
H1: Preterm babies who are breastfed feel less pain during orogastric tube insertion.
H2: Preterm babies given dextrose during orogastric tube insertion feel less pain.
H3: The comfort level of preterm babies who are breastfed during orogastric tube insertion is higher.
H4: The comfort level of preterm babies given dextrose during orogastric tube insertion is higher.
H5: There is a difference between the pain and comfort levels of preterm patients in terms of group, time, and group-time, depending on the intervention applied.
Read the detailed description
The orogastric will then be informed about the investigations of the premature babies to be removed. It will be held in a place where video recordings will be taken from the parent during the orogastric catheter insertion process. After informed consent is obtained, the group to be included will be determined by predetermined stratified randomization.
Standard treatment will be applied to all preterms. Standard approach; Wrapping data during painful and stressful interventions is an effective method to calm the data and shorten the spread (Gardner and Goldson, 2011). As shown by Erkut and Yıldız with 74 newborns, births wrapped during heel bleeding had lower pain scores and higher oxygen saturation temperatures than the control groups (Erkut and Yıldız, 2017). The wrapping application will be wrapped in the flexion and abduction positions of the pre-terms, as a subscription for all members, in a way that does not cause movement restriction.
Babies are cared for every morning between 08.00 and 08.30. During care, orogastric catheters, tubes, and probes are renewed. Hand, face, and body care and oral care are provided and diapers are changed. Orgastric catheters of the babies included in the study will be removed during care hours. Maintenance takes approximately 15 minutes. Wrapping will be applied as standard treatment to all babies included in the study. After the care was done, it was wrapped early and allowed to rest. They are fed at 09.00. Preterms to be included in the study in each group; 30-45 without insertion of orogastric tube. They will be wrapped up in their beds and will be in a rest period where they will not be disturbed until minutes before. Oragastric catheters will be removed before feeding at 9:00. Video recording will be made starting before the procedure of connecting to the oragastric catheter (2 minutes).
- Conditions
- Prematurity, Pain Acute, Comfort, Orogastric Tube Insertion
- Being tested
- breast milk, dextrose
- Medical subject headings
- Premature Birth, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast milkOther
give breast milk before the OG catheter insertion
dextroseOther
give %20 dextrose before the OG catheter insertion
| Study group | Role | What they receive |
|---|---|---|
| Breast milk | Experimental | Breast Milk Intervention: Wrapping was applied to the baby as a standard approach. 2 minutes before the insertion of the oragastric catheter, 2 ml of breast milk was given to the babys mouth with a syringe. After the baby was given breast milk, video recording started. The steps for inserting an orogastric catheter were followed, and the baby was monitored in an incubator during the application, with pulse and saturation monitored. Receives: Other: breast milk |
| Dextrose | Experimental | Dextrose Intervention: The baby will receive wrapping as standard treatment. The orogastric catheter is visible to the brim with 2 ml of 20% dextrose syringe 2 minutes before the insertion chamber (Bueno et al., 2013). After the baby is given dextrose, the video recording will start. The steps of the orogastric tube insertion procedure will be followed. The baby will be in an incubator during the application, with pulse and saturation monitored. Receives: Other: dextrose |
| Control group | No intervention | The control group: Baby will be wrapped as standard treatment. Video recording will start 2 minutes before the baby is inserted into the orogastric catheter. The steps of the orogastric tube insertion procedure will be followed. The baby will be in an incubator during the application, with pulse and saturation monitored. No additional intervention will be applied to the baby. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OG catheter-related pain
Neonatal Infant Pain Scale (NIPS): The Newborn Infant Pain Scale (NIPS) was developed by Lawrence et al. in 1993. Turkish validity and reliability were established by Akdovan in 1999. Reliability values were found to be 0.83, 0.83, and 0.86 before, during, and after the procedure, respectively. The newborn infant pain scale is a Likert-type scale consisting of 6 parameters, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; comfortable, 1; variable-irregular), arm (0: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless).
Measured: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion
OG catheter-related comfort
The Newborn Comfort Behavior Scale: The newborn comfort behavior scale is a Likert-type scale developed to evaluate the comfort needs, pain, and distress of newborn babies. This scale was developed by Ambuel et al. (1992) to evaluate the comfort, pain, and stress status of newborn babies receiving mechanical ventilator support in the intensive care unit. This scale consists of six parameters: alertness, agitation, respiratory response/crying, body movements, facial tension, and muscle tone. Each item on the scale is scored between 1-5. If the total score obtained as a result of the evaluation is below 13, it is emphasized that the baby is comfortable, if it is 14 and above, the baby's comfort level is low, and additional interventions to increase comfort may be required.
Measured: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Mar 2022
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- 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
- Breast Milk Dextrose Control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Sevgi Güven, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222047
- Sponsor's protocol ID
- buchOG
- Acronym
- OGpreterm
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Milk and Dextrose on the Orogastric Tube Insertion-related Pain and Comfort Levels of Preterm Babies
- ClinicalTrials.gov ID
- NCT06222047
- Acronym / sponsor ID
- OGpreterm / buchOG
- Conditions
- Prematurity, Pain Acute, Comfort, Orogastric Tube Insertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 Jan 2024 (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.
Purpose of the research:
This research was planned to evaluate the effect of breast milk and dextrose application, which are pain relief methods, on the pain and comfort levels of preterm babies who will have an orogastric tube inserted in the 3rd and 4th levels of the Neonatal Intensive Care Unit.
Hypotheses:
H0: The methods used during orogastric tube insertion do not affect the pain and comfort levels of preterm babies.
H1: Preterm babies who are breastfed feel less pain during orogastric tube insertion.
H2: Preterm babies given dextrose during orogastric tube insertion feel less pain.
H3: The comfort level of preterm babies who are breastfed during orogastric tube insertion is higher.
H4: The comfort level of preterm babies given dextrose during orogastric tube insertion is higher.
H5: There is a difference between the pain and comfort levels of preterm patients in terms of group, time, and group-time, depending on the intervention applied.
Detailed description
The orogastric will then be informed about the investigations of the premature babies to be removed. It will be held in a place where video recordings will be taken from the parent during the orogastric catheter insertion process. After informed consent is obtained, the group to be included will be determined by predetermined stratified randomization.
Standard treatment will be applied to all preterms. Standard approach; Wrapping data during painful and stressful interventions is an effective method to calm the data and shorten the spread (Gardner and Goldson, 2011). As shown by Erkut and Yıldız with 74 newborns, births wrapped during heel bleeding had lower pain scores and higher oxygen saturation temperatures than the control groups (Erkut and Yıldız, 2017). The wrapping application will be wrapped in the flexion and abduction positions of the pre-terms, as a subscription for all members, in a way that does not cause movement restriction.
Babies are cared for every morning between 08.00 and 08.30. During care, orogastric catheters, tubes, and probes are renewed. Hand, face, and body care and oral care are provided and diapers are changed. Orgastric catheters of the babies included in the study will be removed during care hours. Maintenance takes approximately 15 minutes. Wrapping will be applied as standard treatment to all babies included in the study. After the care was done, it was wrapped early and allowed to rest. They are fed at 09.00. Preterms to be included in the study in each group; 30-45 without insertion of orogastric tube. They will be wrapped up in their beds and will be in a rest period where they will not be disturbed until minutes before. Oragastric catheters will be removed before feeding at 9:00. Video recording will be made starting before the procedure of connecting to the oragastric catheter (2 minutes).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Breast Milk Dextrose Control
| Arm | Type | Receives |
|---|---|---|
| Breast milk | Experimental | Other: breast milkBreast Milk Intervention: Wrapping was applied to the baby as a standard approach. 2 minutes before the insertion of the oragastric catheter, 2 ml of breast milk was given to the babys mouth with a syringe. After the baby was given breast milk, video recording started. The steps for inserting an orogastric catheter were followed, and the baby was monitored in an incubator during the application, with pulse and saturation monitored. |
| Dextrose | Experimental | Other: dextroseDextrose Intervention: The baby will receive wrapping as standard treatment. The orogastric catheter is visible to the brim with 2 ml of 20% dextrose syringe 2 minutes before the insertion chamber (Bueno et al., 2013). After the baby is given dextrose, the video recording will start. The steps of the orogastric tube insertion procedure will be followed. The baby will be in an incubator during the application, with pulse and saturation monitored. |
| Control group | No intervention | –The control group: Baby will be wrapped as standard treatment. Video recording will start 2 minutes before the baby is inserted into the orogastric catheter. The steps of the orogastric tube insertion procedure will be followed. The baby will be in an incubator during the application, with pulse and saturation monitored. No additional intervention will be applied to the baby. |
Who may qualify
- Ages
- 32 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Birth week 32-34,
Key exclusion criteria (6 listed)
- In need of oxygen support,
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 |
|---|---|---|
| breast milkgive breast milk before the OG catheter insertion | Other | Breast milk |
| dextrosegive %20 dextrose before the OG catheter insertion | Other | Dextrose |
Primary outcome
OG catheter-related pain
Time frame: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion
Neonatal Infant Pain Scale (NIPS): The Newborn Infant Pain Scale (NIPS) was developed by Lawrence et al. in 1993. Turkish validity and reliability were established by Akdovan in 1999. Reliability values were found to be 0.83, 0.83, and 0.86 before, during, and after the procedure, respectively. The newborn infant pain scale is a Likert-type scale consisting of 6 parameters, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; comfortable, 1; variable-irregular), arm (0: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless).
OG catheter-related comfort
Time frame: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion
The Newborn Comfort Behavior Scale: The newborn comfort behavior scale is a Likert-type scale developed to evaluate the comfort needs, pain, and distress of newborn babies. This scale was developed by Ambuel et al. (1992) to evaluate the comfort, pain, and stress status of newborn babies receiving mechanical ventilator support in the intensive care unit. This scale consists of six parameters: alertness, agitation, respiratory response/crying, body movements, facial tension, and muscle tone. Each item on the scale is scored between 1-5. If the total score obtained as a result of the evaluation is below 13, it is emphasized that the baby is comfortable, if it is 14 and above, the baby's comfort level is low, and additional interventions to increase comfort may be required.
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 24 Jan 2024.
- 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.
Sevgi Güven study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breast milk and dextrose in people with Prematurity and Pain Acute, run by Dokuz Eylul University at 1 site 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 8 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
OG catheter-related pain (time frame: 2 minutes before the OG tube insertion, during the OG tube insertion, 2 minutes after the OG tube insertion). The study lists 2 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 24 Jan 2024.