PrematureOGTNCT05180058
Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol with Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose
A study testing Wrapping + Breastmilk Group in people with Premature and Orogastric Tube, run by Ayse Sonay Turkmen, Prof.Dr at 2 sites in Turkey (Türkiye).
Trial summary
This study aimed to reduce the pain and increase comfort during the orogastric tube insertion (OGT) procedure, which is routinely applied to feed these babies at 32-34 weeks of age, in preterm newborns with a sucking reflex.In addition, this study also aimed to develop an atraumatic OGT attachment protocol by… Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Premature, Orogastric Tube, Oral Sucrose
- What is being tested?
- Wrapping + Breastmilk Group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 Sep 2022
- 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 1 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational week is between 32 and 34 weeks
- Having breast milk
- Stable health status
- Spontaneous breathing
- Being fed by an orogastric tube
- Not being exposed to a painful procedure at least half an hour before the interventions
- Not taking opioid or non-opioid analgesics
Who cannot join
- newborns who did not meet the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
KaramanogluMehmetbeyU
Karaman, Turkey, 70100
Karamanoglu Mehmetbey University
Karaman
About this study
This study aimed to reduce the pain and increase comfort during the orogastric tube insertion (OGT) procedure, which is routinely applied to feed these babies at 32-34 weeks of age, in preterm newborns with a sucking reflex.In addition, this study also aimed to develop an atraumatic OGT attachment protocol by combining wrapping, fetal position, breast milk and oral sucrose combined therapy.
It was planned as a randomized double-blind and controlled experimental study to evaluate the efficacy of using In addition, this study also planned to develop the atraumatic OGT insertion procedure through combined therapy of wrapping, fetal position, breast milk, and oral sucrose. The population of the research consists of preterm babies who are treated in the Neonatal Intensive Care Unit of Selcuk University Hospital. Babies to be sampled are preterm babies who are between 32 and 34 weeks of gestation.
Read more
Preterm newborns will be randomly divided into five groups;
- Group 1: Control
- Group 2: Wrapping + breast milk (2 ml)
- Group 3: Wrapping + oral sucrose (0.2 ml/kg 20% sucrose)
- Group 4: Fetal position + breast milk (2 ml)
- Group 5: Fetal position + oral sucrose (0.2 ml/kg 20% sucrose) In the NICU, OGT insertion will be performed by the clinical nurse as part of the treatment for preterm newborns, which the clinic physician deems necessary. The clinical nurse and clinician will be responsible for OGT insertion in preterm newborns. In this study, only wrapping, fetal positioning, oral breast milk and sucrose delivery methods will be applied to preterm newborns by the researcher. In this context, the responsibility of the researcher in the study will be to apply non-pharmacological methods to preterm newborns only before OGT insertion and to evaluate the pain symptoms in preterm newborns during and after OGT insertion.
The obtained data will be evaluated in SPSS-21 package program in computer environment. Normality tests, chi-square, t test, Anova, and advanced analysis will be used when necessary in the analysis of the data. The relationship between the mean score of the scale and other variables will be evaluated by correlation regression analysis. Significance will be accepted as p<0.05.
Read the detailed description
Ethical and institutional permissions were obtained before starting to collect the data. Written consent will be obtained from all parents via a voluntary consent form. Preterm newborns will be randomly selected into 5 groups.
- Group 1 (Control Group); Wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal position+breastmilk methods were not applied to preterms in the routine care group. However, in order to be an ethical practice and to provide ethical standard care intervention, verbal relaxation and soft touch applications were applied by the researcher in the procedure.
- Group 2 (Wrapping + Breastmilk Group); Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by the researcher with a sterile syringe 2 minutes before the OGT insertion to the same newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
- Group 3 (Wrapping + Oral Sucrose Group); Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given to the same newborn by the researcher with a sterile syringe 2 minutes before OGT insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn on the upper part of the tongue through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at 1 minute before the procedure, during and after the procedure at 1 minute and 2 minutes (4 measurements).
- Group 4 (Fetal Position + Breastmilk Group); The fetal position will be given to the preterm newborn immediately after 2 ml of breast milk is given by the researcher 3 minutes before OGT insertion. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
- Group 5 (Fetal Position + Oral Sucrose Group); The fetal position will be given to the preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3 minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the preterm newborn on the upper part of the tongue by means of an injector. At the end of the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure.
Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
Hypotheses (H1) There is a significant difference between the methods applied in the OGT insertion procedure (wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal position+breastmilk) in terms of heart rate in preterms.
There is a significant difference between the methods applied in the (H2) OGT insertion procedure in terms of oxygen saturation of preterms.
(H3) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the estimated pain score of preterms.
(H4) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the estimated distress score of preterms.
(H5) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the comfort level of preterms.
(H6) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the mean of preterm pain in preterms.
- Conditions
- Premature, Orogastric Tube, Oral Sucrose
- Being tested
- Wrapping + Breastmilk Group
- Keywords
- Premature, orogastric tube, oral sucrose, Wrapping
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrapping + Breastmilk GroupOther
Also called Wrapping + Oral Sucrose Group, Fetal Position + Breastmilk Group, Fetal Position + Oral Sucrose Group
Interventions applied during orogastric tube insertion
| Study group | Role | What they receive |
|---|---|---|
| Wrapping + Breastmilk Group | Experimental | Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by the researcher with a sterile syringe 2 minutes before the OGT insertion to the same newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure. Receives: Other: Wrapping + Breastmilk Group |
| Wrapping + Oral Sucrose Group | Experimental | Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given to the same newborn by the researcher with a sterile syringe 2 minutes before OGT insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn on the upper part of the tongue through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at 1 minute before the procedure, during and after the procedure at 1 minute and 2 minutes (4 measurements). Receives: Other: Wrapping + Breastmilk Group |
| Fetal Position + Breastmilk Group | Experimental | The fetal position will be given to the preterm newborn immediately after 2 ml of breast milk is given by the researcher 3 minutes before OGT insertion. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure. Receives: Other: Wrapping + Breastmilk Group |
| Fetal Position + Oral Sucrose Group | Experimental | The fetal position will be given to the preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3 minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the preterm newborn on the upper part of the tongue by means of an injector. At the end of the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Receives: Other: Wrapping + Breastmilk Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
heart rate before, during and after the procedure (1st and 2nd min.)
Measured: 5 minutes
oxygen saturation values
oxygen saturation values before, during and after the procedure (1st and 2nd min.)
Measured: 5 minutes
PIPP Scale
pain scores before, during and after the procedure (1st and 2nd min.)
Measured: 5 minutes
comfort scale score
comfort scores before, during and after the procedure (1st and 2nd min.)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start15 Feb 2022
- Primary completion30 Jun 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayse Sonay Turkmen, Prof.Dr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayse Sonay Turkmen, Prof.Dr, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180058
- Sponsor's protocol ID
- oral nasogastric tube
- Acronym
- OGT
- Status last verified
- Nov 2022
- First submitted
- 17 Dec 2021
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apaydin Cirik V, Turkmen AS, Derin E, Yilmaz N. Effectiveness of an atraumatic orogastric tube insertion protocol for the combined use of swaddling, facilitated tucking, breast milk and sucrose. Int J Nurs Pract. 2024 Dec;30(6):e13293. doi: 10.1111/ijn.13293. Epub 2024 Jul 29.
PubMed 39075946
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol with Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose
- ClinicalTrials.gov ID
- NCT05180058
- Acronym / sponsor ID
- OGT / oral nasogastric tube
- Conditions
- Premature, Orogastric Tube, Oral Sucrose
- Keywords
- Premature, orogastric tube, oral sucrose, Wrapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ayse Sonay Turkmen, Prof.DrUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 6 Jan 2022 (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.
This study aimed to reduce the pain and increase comfort during the orogastric tube insertion (OGT) procedure, which is routinely applied to feed these babies at 32-34 weeks of age, in preterm newborns with a sucking reflex.In addition, this study also aimed to develop an atraumatic OGT attachment protocol by combining wrapping, fetal position, breast milk and oral sucrose combined therapy.
It was planned as a randomized double-blind and controlled experimental study to evaluate the efficacy of using In addition, this study also planned to develop the atraumatic OGT insertion procedure through combined therapy of wrapping, fetal position, breast milk, and oral sucrose. The population of the research consists of preterm babies who are treated in the Neonatal Intensive Care Unit of Selcuk University Hospital. Babies to be sampled are preterm babies who are between 32 and 34 weeks of gestation.
Preterm newborns will be randomly divided into five groups;
- Group 1: Control
- Group 2: Wrapping + breast milk (2 ml)
- Group 3: Wrapping + oral sucrose (0.2 ml/kg 20% sucrose)
- Group 4: Fetal position + breast milk (2 ml)
- Group 5: Fetal position + oral sucrose (0.2 ml/kg 20% sucrose) In the NICU, OGT insertion will be performed by the clinical nurse as part of the treatment for preterm newborns, which the clinic physician deems necessary. The clinical nurse and clinician will be responsible for OGT insertion in preterm newborns. In this study, only wrapping, fetal positioning, oral breast milk and sucrose delivery methods will be applied to preterm newborns by the researcher. In this context, the responsibility of the researcher in the study will be to apply non-pharmacological methods to preterm newborns only before OGT insertion and to evaluate the pain symptoms in preterm newborns during and after OGT insertion.
The obtained data will be evaluated in SPSS-21 package program in computer environment. Normality tests, chi-square, t test, Anova, and advanced analysis will be used when necessary in the analysis of the data. The relationship between the mean score of the scale and other variables will be evaluated by correlation regression analysis. Significance will be accepted as p<0.05.
Detailed description
Ethical and institutional permissions were obtained before starting to collect the data. Written consent will be obtained from all parents via a voluntary consent form. Preterm newborns will be randomly selected into 5 groups.
- Group 1 (Control Group); Wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal position+breastmilk methods were not applied to preterms in the routine care group. However, in order to be an ethical practice and to provide ethical standard care intervention, verbal relaxation and soft touch applications were applied by the researcher in the procedure.
- Group 2 (Wrapping + Breastmilk Group); Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by the researcher with a sterile syringe 2 minutes before the OGT insertion to the same newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
- Group 3 (Wrapping + Oral Sucrose Group); Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given to the same newborn by the researcher with a sterile syringe 2 minutes before OGT insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn on the upper part of the tongue through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at 1 minute before the procedure, during and after the procedure at 1 minute and 2 minutes (4 measurements).
- Group 4 (Fetal Position + Breastmilk Group); The fetal position will be given to the preterm newborn immediately after 2 ml of breast milk is given by the researcher 3 minutes before OGT insertion. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
- Group 5 (Fetal Position + Oral Sucrose Group); The fetal position will be given to the preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3 minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the preterm newborn on the upper part of the tongue by means of an injector. At the end of the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure.
Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
Hypotheses (H1) There is a significant difference between the methods applied in the OGT insertion procedure (wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal position+breastmilk) in terms of heart rate in preterms.
There is a significant difference between the methods applied in the (H2) OGT insertion procedure in terms of oxygen saturation of preterms.
(H3) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the estimated pain score of preterms.
(H4) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the estimated distress score of preterms.
(H5) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the comfort level of preterms.
(H6) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the mean of preterm pain in preterms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wrapping + Breastmilk Group | Experimental | Other: Wrapping + Breastmilk GroupPreterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by the researcher with a sterile syringe 2 minutes before the OGT insertion to the same newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure. |
| Wrapping + Oral Sucrose Group | Experimental | Other: Wrapping + Breastmilk GroupPreterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given to the same newborn by the researcher with a sterile syringe 2 minutes before OGT insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn on the upper part of the tongue through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at 1 minute before the procedure, during and after the procedure at 1 minute and 2 minutes (4 measurements). |
| Fetal Position + Breastmilk Group | Experimental | Other: Wrapping + Breastmilk GroupThe fetal position will be given to the preterm newborn immediately after 2 ml of breast milk is given by the researcher 3 minutes before OGT insertion. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure. |
| Fetal Position + Oral Sucrose Group | Experimental | Other: Wrapping + Breastmilk GroupThe fetal position will be given to the preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3 minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the preterm newborn on the upper part of the tongue by means of an injector. At the end of the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Gestational week is between 32 and 34 weeks
- Having breast milk
- Stable health status
- Spontaneous breathing
- Being fed by an orogastric tube
Key exclusion criteria (1 listed)
- newborns who did not meet the inclusion criteria
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 |
|---|---|---|
| Wrapping + Breastmilk GroupAlso: Wrapping + Oral Sucrose Group, Fetal Position + Breastmilk Group, Fetal Position + Oral Sucrose GroupInterventions applied during orogastric tube insertion | Other | Fetal Position + Breastmilk Group, Fetal Position + Oral Sucrose Group, Wrapping + Breastmilk Group, Wrapping + Oral Sucrose Group |
Primary outcome
heart rate
Time frame: 5 minutes
heart rate before, during and after the procedure (1st and 2nd min.)
oxygen saturation values
Time frame: 5 minutes
oxygen saturation values before, during and after the procedure (1st and 2nd min.)
PIPP Scale
Time frame: 5 minutes
pain scores before, during and after the procedure (1st and 2nd min.)
comfort scale score
Time frame: 5 minutes
comfort scores before, during and after the procedure (1st and 2nd min.)
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 10 Jan 2025.
- Derived from this study: PubMed 39075946Apaydin Cirik V, Turkmen AS, Derin E, Yilmaz N. Effectiveness of an atraumatic orogastric tube insertion protocol for the combined use of swaddling, facilitated tucking, breast milk and sucrose. Int J Nurs Pract. 2024 Dec;30(6):e13293. doi: 10.1111/ijn.13293. Epub 2024 Jul 29.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrapping + Breastmilk Group in people with Premature and Orogastric Tube, run by Ayse Sonay Turkmen, Prof.Dr 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 1 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 10 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?
heart rate (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180058, which also lists 1 linked publication.
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 10 Jan 2025.