Newborn; VitalityNCT06706115
Effect of Intranasal Breast Milk Administration in Preterm Infants
A study testing Intranasal human breast milk in people with Newborn; Vitality and Nursing Caries, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants. Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Newborn; Vitality, Nursing Caries, Breast Feeding
- What is being tested?
- Intranasal human breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth weight >1000 gr,
- APGAR score >7 at 5 minutes after birth,
- Availability of breast milk,
- No medical diagnosis affecting cerebral oxygenation (intraventricular hemorrhage, cardiovascular and neurological disorders, anemia),
- No congenital anomalies or chromosomal abnormalities,
- No congenital anomaly (such as cleft palate) affecting nasal patency.
Who cannot join
- Being able to feed orally in all feedings
- Being fed entirely on formula milk,
- Administration of medication via the nasal route,
- Being intubated or receiving continuous positive air pressure (CPAP) support,
- Maternal substance abuse, alcohol abuse, HIV infection, untreated active tuberculosis, chemotherapy or radiotherapy treatment,
- The mother has mastitis, breast trauma, abscesses or is taking any medication that passes into the milk,
- The mother does not want to express milk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selcuk University
Konya
Sibel Küçükoğlu, Prof, s_nadaroglu@hotmail.com
About this study
Official title: : Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
Read the detailed description
Breast milk is rich in pluripotent stem cells, including pluripotent stem cells that produce neuronal cells in vitro. Therefore, intranasal breast milk administration in neonates may potentially allow the transport of stem cells and other molecules into brain tissue through the nasal vasculature and permeable neonatal blood-brain barrier. In recent years, studies on intranasal breast milk administration in newborns have been published. In studies, there is evidence that intranasal breast milk may be effective in reducing cerebral damage after intracranial hemorrhage in preterm newborns and that the application can be tolerated by preterm newborns.
- Conditions
- Newborn; Vitality, Nursing Caries, Breast Feeding
- Being tested
- Intranasal human breast milk
- Keywords
- Breast milk, Newborn Nursing, Oral Nutrition, Physiological parameters, Preterm infant
- Medical subject headings
- Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal human breast milkOther
The information in the "Physiologic Parameter Follow-up Form" will be recorded by the investigator just 5 minutes before the intervention. The researcher will drip 0.2 ml of breast milk at room temperature (approximately 22 °C) into the nose of the infant lying in the supine position, 0.1 ml in the right nose-0.1 ml in the left nose. 5 minutes after the intervention (T1), 15 minutes after the intervention (T2) and 30 minutes after the intervention (T3), the data in the "Physiologic Parameter Follow-up Form" will be recorded by the researcher. After intranasal breast milk administration, the baby will be fed by the neonatal nurse as in routine practice. The implementation of the intervention in the study will last for three days and this process will be repeated three times every day (09.00, 12.00 and 15.00).
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Breast Milk Group | Experimental | Preterm infants (28-37 gestation week) in the intervention group will receive 0.2 ml of breast milk intranasally three times a day for three days. Receives: Other: Intranasal human breast milk |
| Control Group | No intervention | Preterm newborns in the control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Information Form
The form developed by the researchers in line with the literature includes the identifying information of the preterm infant (gender, date of birth, gestational week at birth, mode of delivery, APGAR score, birth weight, postmenstrual age)
Measured: First measurement-First day of hospitalization
Physiologic Parameter Follow-up Form-Cerebral rSO2
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Measured: First measurement- 5 minutes before the intervention (T0)
Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)
Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Measured: First measurement- 5 minutes before the intervention (T0)
Physiologic Parameter Follow-up Form-Heart Rate (HR)
Heart rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Measured: First measurement- 5 minutes before the intervention (T0)
Physiologic Parameter Follow-up Form-Respiratory rate
Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Measured: First measurement- 5 minutes before the intervention (T0)
Nutrition Follow-up Form-intranasal breast milk content
Intranasal breast milk content (fresh/thawed) in the Nutrition Follow-up Form will be recorded before the intervention.
Measured: First measurement- intranasal breast milk content
Secondary outcomes (17)
Physiologic Parameter Follow-up Form -Cerebral rSO2
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.
Measured: Second measurement- 5. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Cerebral rSO2
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.
Measured: Second measurement- 15. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Cerebral rSO2
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Measured: Second measurement- 30. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.
Measured: Second measurement- 5. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.
Measured: Second measurement- 15. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Measured: Second measurement- 30. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Heart Rate (HR)
Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.
Measured: Second measurement- 5. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Heart Rate (HR)
Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.
Measured: Second measurement- 15. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Heart Rate (HR)
Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Measured: Second measurement- 30. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Respiratory rate
Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.
Measured: Second measurement- 5. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Respiratory rate
Respiratory rate in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.
Measured: Second measurement- 15. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Respiratory rate
Respiratory rate in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Measured: Second measurement- 30. minutes after the intervention (T1)
Nutrition Follow-up Form-Nutrient content
Nutrient content (exclusive breast milk/formula+ breast milk feeding) in the Nutrition Follow-up Form will be recorded 5 minutes after the intervention.
Measured: Second measurement-Nutrient content
Nutrition Follow-up Form-Number of vomits
Number of vomits in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.
Measured: Second measurement- Number of vomits
Nutrition Follow-up Form-Number of defecations
Number of defecations in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.
Measured: Second measurement- Number of defecations
Nutrition Follow-up Form-The time of transition to full oral feeding
The time of transition to full oral feeding, which is found on the Feeding Follow-up Form, will be monitored and recorded in medical records until the baby is discharged.
Measured: Second measurement- The time of transition to full oral feeding
Nutrition Follow-up Form-Discharge time
Discharge time, which is found on the Feeding Follow-up Form, will be monitored and recorded in medical records until the baby is discharged.
Measured: Second measurement- Discharge time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start30 Jun 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Newborn; VitalityStudies 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
- Randomized controlled design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, Prof, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706115
- Sponsor's protocol ID
- SelcukUni2545
- Status last verified
- Nov 2024
- First submitted
- 21 May 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Keller T, Korber F, Oberthuer A, Schafmeyer L, Mehler K, Kuhr K, Kribs A. Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation. Eur J Pediatr. 2019 Feb;178(2):199-206. doi: 10.1007/s00431-018-3279-7. Epub 2018 Nov 1.
PubMed 30386923Hoban R, Gallipoli A, Signorile M, Mander P, Gauthier-Fisher A, Librach C, Wilson D, Unger S. Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage. J Perinatol. 2024 Nov;44(11):1652-1657. doi: 10.1038/s41372-024-01982-8. Epub 2024 Apr 30.
PubMed 38688998Muelbert M, Alexander T, Pook C, Jiang Y, Harding JE, Bloomfield FH. Cortical Oxygenation Changes during Gastric Tube Feeding in Moderate- and Late-Preterm Babies: A NIRS Study. Nutrients. 2021 Jan 25;13(2):350. doi: 10.3390/nu13020350.
PubMed 33503882Yucel A, Kucukoglu S, Soylu H. The Effect of Breast Milk Odor on Feeding Cues, Transition Time to Oral Feeding, and Abdominal Perfusion in Premature Newborns: A Randomised Controlled Trial. Biol Res Nurs. 2024 Jan;26(1):160-175. doi: 10.1177/10998004231200784. Epub 2023 Sep 8.
PubMed 37682253Yucel A, Kucukoglu S, Konak M. Effect of intranasal breast milk administration on cerebral oxygenation, vital signs, and transition time to full oral feeding in preterm infants: a randomized controlled study. Eur J Pediatr. 2026 Apr 16;185(5):272. doi: 10.1007/s00431-026-06922-6.
PubMed 41986747Yucel A, Kucukoglu S, Konak M. The Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Time to Full Oral Feeding in Preterm Infants: a Randomised Controlled Study Protocol. Nurs Crit Care. 2026 Jan;31(1):e70262. doi: 10.1111/nicc.70262.
PubMed 41542903
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06706115
- Acronym / sponsor ID
- SelcukUni2545
- Conditions
- Newborn; Vitality, Nursing Caries, Breast Feeding
- Keywords
- Breast milk, Newborn Nursing, Oral Nutrition, Physiological parameters, Preterm infant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Nov 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.
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
Detailed description
Breast milk is rich in pluripotent stem cells, including pluripotent stem cells that produce neuronal cells in vitro. Therefore, intranasal breast milk administration in neonates may potentially allow the transport of stem cells and other molecules into brain tissue through the nasal vasculature and permeable neonatal blood-brain barrier. In recent years, studies on intranasal breast milk administration in newborns have been published. In studies, there is evidence that intranasal breast milk may be effective in reducing cerebral damage after intracranial hemorrhage in preterm newborns and that the application can be tolerated by preterm newborns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Intranasal Breast Milk Group | Experimental | Other: Intranasal human breast milkPreterm infants (28-37 gestation week) in the intervention group will receive 0.2 ml of breast milk intranasally three times a day for three days. |
| Control Group | No intervention | –Preterm newborns in the control group will not receive any intervention. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birth weight >1000 gr,
- APGAR score >7 at 5 minutes after birth,
- Availability of breast milk,
- No medical diagnosis affecting cerebral oxygenation (intraventricular hemorrhage, cardiovascular and neurological disorders, anemia),
- No congenital anomalies or chromosomal abnormalities,
Key exclusion criteria (7 listed)
- Being able to feed orally in all feedings
- Being fed entirely on formula milk,
- Administration of medication via the nasal route,
- Being intubated or receiving continuous positive air pressure (CPAP) support,
- Maternal substance abuse, alcohol abuse, HIV infection, untreated active tuberculosis, chemotherapy or radiotherapy treatment,
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 |
|---|---|---|
| Intranasal human breast milkThe information in the "Physiologic Parameter Follow-up Form" will be recorded by the investigator just 5 minutes before the intervention. The researcher will drip 0.2 ml of breast milk at room temperature (approximately 22 °C) into the nose of the infant lying in the supine position, 0.1 ml in the right nose-0.1 ml in the left nose. 5 minutes after the intervention (T1), 15 minutes after the intervention (T2) and 30 minutes after the intervention (T3), the data in the "Physiologic Parameter Follow-up Form" will be recorded by the researcher. After intranasal breast milk administration, the baby will be fed by the neonatal nurse as in routine practice. The implementation of the intervention in the study will last for three days and this process will be repeated three times every day (09.00, 12.00 and 15.00). | Other | Intranasal Breast Milk Group |
Primary outcome
Infant Information Form
Time frame: First measurement-First day of hospitalization
The form developed by the researchers in line with the literature includes the identifying information of the preterm infant (gender, date of birth, gestational week at birth, mode of delivery, APGAR score, birth weight, postmenstrual age)
Physiologic Parameter Follow-up Form-Cerebral rSO2
Time frame: First measurement- 5 minutes before the intervention (T0)
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)
Time frame: First measurement- 5 minutes before the intervention (T0)
Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Physiologic Parameter Follow-up Form-Heart Rate (HR)
Time frame: First measurement- 5 minutes before the intervention (T0)
Heart rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Physiologic Parameter Follow-up Form-Respiratory rate
Time frame: First measurement- 5 minutes before the intervention (T0)
Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Nutrition Follow-up Form-intranasal breast milk content
Time frame: First measurement- intranasal breast milk content
Intranasal breast milk content (fresh/thawed) in the Nutrition Follow-up Form will be recorded before the intervention.
17 secondary outcomes
Physiologic Parameter Follow-up Form -Cerebral rSO2
Time frame: Second measurement- 5. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Cerebral rSO2
Time frame: Second measurement- 15. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Cerebral rSO2
Time frame: Second measurement- 30. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
Time frame: Second measurement- 5. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
Time frame: Second measurement- 15. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
Time frame: Second measurement- 30. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Heart Rate (HR)
Time frame: Second measurement- 5. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Heart Rate (HR)
Time frame: Second measurement- 15. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Heart Rate (HR)
Time frame: Second measurement- 30. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Respiratory rate
Time frame: Second measurement- 5. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Respiratory rate
Time frame: Second measurement- 15. minutes after the intervention (T1)
Physiologic Parameter Follow-up Form -Respiratory rate
Time frame: Second measurement- 30. minutes after the intervention (T1)
Nutrition Follow-up Form-Nutrient content
Time frame: Second measurement-Nutrient content
Nutrition Follow-up Form-Number of vomits
Time frame: Second measurement- Number of vomits
Nutrition Follow-up Form-Number of defecations
Time frame: Second measurement- Number of defecations
Nutrition Follow-up Form-The time of transition to full oral feeding
Time frame: Second measurement- The time of transition to full oral feeding
Nutrition Follow-up Form-Discharge time
Time frame: Second measurement- Discharge time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 30386923Keller T, Korber F, Oberthuer A, Schafmeyer L, Mehler K, Kuhr K, Kribs A. Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation. Eur J Pediatr. 2019 Feb;178(2):199-206. doi: 10.1007/s00431-018-3279-7. Epub 2018 Nov 1.
- Background: PubMed 38688998Hoban R, Gallipoli A, Signorile M, Mander P, Gauthier-Fisher A, Librach C, Wilson D, Unger S. Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage. J Perinatol. 2024 Nov;44(11):1652-1657. doi: 10.1038/s41372-024-01982-8. Epub 2024 Apr 30.
- Background: PubMed 33503882Muelbert M, Alexander T, Pook C, Jiang Y, Harding JE, Bloomfield FH. Cortical Oxygenation Changes during Gastric Tube Feeding in Moderate- and Late-Preterm Babies: A NIRS Study. Nutrients. 2021 Jan 25;13(2):350. doi: 10.3390/nu13020350.
- Background: PubMed 37682253Yucel A, Kucukoglu S, Soylu H. The Effect of Breast Milk Odor on Feeding Cues, Transition Time to Oral Feeding, and Abdominal Perfusion in Premature Newborns: A Randomised Controlled Trial. Biol Res Nurs. 2024 Jan;26(1):160-175. doi: 10.1177/10998004231200784. Epub 2023 Sep 8.
- Derived from this study: PubMed 41986747Yucel A, Kucukoglu S, Konak M. Effect of intranasal breast milk administration on cerebral oxygenation, vital signs, and transition time to full oral feeding in preterm infants: a randomized controlled study. Eur J Pediatr. 2026 Apr 16;185(5):272. doi: 10.1007/s00431-026-06922-6.
- Derived from this study: PubMed 41542903Yucel A, Kucukoglu S, Konak M. The Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Time to Full Oral Feeding in Preterm Infants: a Randomised Controlled Study Protocol. Nurs Crit Care. 2026 Jan;31(1):e70262. doi: 10.1111/nicc.70262.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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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.
Sibel Kucukoglu, Prof principal investigator
Selcuk 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 Intranasal human breast milk in people with Newborn; Vitality and Nursing Caries, run by Selcuk 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibel Kucukoglu, Prof (+903322230789 ext. 31623, s_nadaroglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Information Form (time frame: First measurement-First day of hospitalization). The study lists 6 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 NCT06706115, which also lists 6 linked publications.
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 26 Nov 2024.