Newborn PretermNCT07079878
The Effect of Bed Head Height During Feeding With Orogastric Catheter on Neonatal Growth
A study testing Group with Bed Head Height 30° and Group with Bed Head Height 45° in people with Newborn Preterm, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
Aim:The study was planned as a randomised controlled experimental study to determine the effect of bed head height applied during feeding with orogastric catheter on growth parameters and feeding tolerance of preterm newborns. Method: The study was a randomised controlled experimental study. Read more about this study
- Who is it for?
- Ages 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Newborn Preterm
- What is being tested?
- Group with Bed Head Height 30° and Group with Bed Head Height 45°
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2024to 5 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 1 day to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The newborn should be in the 32-36th postnatal week
- The weight of the newborn should be over 1500 grams
- The newborn should be able to meet at least 75% of the protein and energy amount that he/she should take through the enteral route
- The newborn should be fed with an orogastric catheter
- The newborn should not need a mechanical ventilator
- The newborn should not have a congenital anomaly
- The parents should volunteer to participate in the study.
Who cannot join
- Neonates with NEC
- Newborns whose bedhead height cannot be provided due to any condition
- Previous findings of feeding intolerance
- Having a chest tube
- Parents not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bed Head Height During Feeding With Orogastric Catheter on Neonatal Growth Parameters and Feeding Tolerance in Preterm Newborns
Aim:The study was planned as a randomised controlled experimental study to determine the effect of bed head height applied during feeding with orogastric catheter on growth parameters and feeding tolerance of preterm newborns.
Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 newbornMethod: The study was a randomised controlled experimental study. The sample of the study consisted of 96 preterm newborns (control: 32, Group with 30° Bed Head Height: 32, Group with 45° Bed Head Height: 32) ). Data Collection Form was used as a data collection tool. The head of the newborns in the intervention group will be raised before the orogastric catheter is inserted, and the children in the control group will be routinely positioned. In this process, physiological parameters of newborns before and after positioning will be followed.
Read the detailed description
The population of the study, which is planned as a prospective randomised controlled experimental study, will consist of preterm newborns hospitalised in the Neonatal Intensive Care Unit of Mersin City Hospital. While determining the sample size of the study, the scientific study titled 'Effects of the prone position and kangaroo care on gastric residual volume, vital signs and comfort in preterm infants' by Özdel \& Sarı (2020) was taken as a basis as a result of literature reviews in order to determine the effect size sample size. As a result of the Power analysis (G*Power 3.1.9.2) performed according to Özdel \& Sarı (2020) study; effect size = 0.967, 95% confidence interval, 95% power, it was calculated that a total of 87 newborns, at least 29 in each group, should be included. Considering the possibility of drop outs and confounding variables in the research process, the number in the groups was increased by 10%. The sample of the study was determined as 96 newborns in total, 32 newborns in each group. Randomisation In the study, 96 children in the sample will be randomly assigned to the control group, the 1st study group (Group with 30° Bed Head Height) and the 2nd study group (Group with 45° Bed Head Height). Random assignment will be made using a computer programme to determine the group of children (https://www.randomlists.com/team-generator).Place and Time of the Study The study will be conducted between July 2024 and March 2025 in the Neonatal Intensive Care Unit of Mersin City Hospital. Mersin City Hospital Obstetrics and Gynaecology Department has 2 Neonatal Intensive Care Units on the 2nd floor and 3rd floor. Research 2nd floor. In the Neonatal Intensive Care Unit, 2nd step and 3rd step patients are cared for. There are 30 incubators in the unit. Newborns with prematurity, congenital anomalies, respiratory distress, maternal preeclampsia, maternal diabetes mellitus, hypoglycaemia, and Exchange borderline phototherapy need are admitted to the Neonatal Intensive Care Unit.Data CollectionIn the study, preterm newborns who are fed with orogastric catheter in the Neonatal Intensive Care Unit will first be evaluated in terms of sampling criteria, and newborns who do not meet the criteria will be excluded from the study. The nurse who collects the data and assesses vital signs and nutritional tolerance will be the investigator herself (Nurse Özlem BORAK). Feeding of the newborns in all groups will be done in accordance with the 'Enteral Nutrition Protocol': Before starting the study, nurses working in the clinic will be trained in enteral nutrition in accordance with the 'Enteral Nutrition Protocol'.2: After obtaining written consent from the parent of the preterm baby to be fed with orogastric catheter, the application of feeding with orogastric catheter and what to be done during the procedure will be explained to the parent. Then, the newborn information form will be filled out.Stage 3: After the groups are determined in accordance with the randomisation table, the necessary materials are prepared in accordance with the feeding protocol. Stage 4: 30 minutes before feeding, the bed head height will be adjusted appropriately.5: The vital signs of the newborn (fever, pulse, respiration, oxygen saturation) will be measured 30 minutes before feeding.6: Feeding will be applied at a height of 15-20 cm, without applying pressure, at its own flow rate in 20 minutes. Stage 7: Vital signs (fever, pulse, respiration, oxygen saturation) will be measured during and 30 minutes after feeding. Stage 8: Abdominal distension will be evaluated before and 2 hours after feeding to assess nutritional tolerance. Abdominal circumference will be measured at the same time every day. Vomiting will be monitored after feeding.9: When evaluating growth parameters, weight monitoring, head circumference and height parameters will be evaluated. Weight will be monitored every day. Head circumference and height will be evaluated on the 1st and 7th days.
- Conditions
- Newborn Preterm
- Being tested
- Group with Bed Head Height 30°, Group with Bed Head Height 45°
- Keywords
- preterm, oragastrik beslenme, beslenme, pozisyon
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group with Bed Head Height 30°Other
30 minutes before feeding, the bed head height of the preterm newborn is adjusted to 30° and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days.
Group with Bed Head Height 45°Other
The bed head height of the preterm newborn is adjusted to 45° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Group with Bed Head Height 30° | Experimental | In the preterm newborn lying in the neonatal intensive care unit, the bed head height is adjusted to 30° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form. Receives: Other: Group with Bed Head Height 30° |
| Group with Bed Head Height 45° | Experimental | The head of the bed of the preterm newborn lying in the neonatal intensive care unit is adjusted to 45° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form. Receives: Other: Group with Bed Head Height 45° |
| Control Group | No intervention | The bed head height of the preterm newborn lying in the neonatal intensive care unit is adjusted in accordance with the clinical routine (15°) and vital signs are monitored 30 minutes before feeding. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Information Form
The information form was prepared by reviewing the relevant literature (Özdel, 2017). The neonatal information form includes 14 items including mode of delivery, 1st and 5th minute APGAR score, gestational age, birth weight, birth weight, birth head circumference, birth length, gender, mother's history of any disease during pregnancy, hospitalisation diagnosis, postnatal age, weight, height and head circumference at the time of assessment.This form will be used to identify the newborn. The average values will be calculated based on age (in days), weight (in kg), and height (in cm).
Measured: 1 day
Newborn Monitoring Form
The follow-up form was prepared based on a review of the relevant literature (Özdel, 2017; Yüce 2020). In the newborn follow-up form, vital signs such as body temperature (Celsius), heart rate (beats per minute), respiratory rate (breaths per minute) and oxygen saturation (percentage) will be measured in the morning and evening for 7 days, and abdominal distension, abdominal circumference measurement (cm), and vomiting status will be assessed in terms of feeding tolerance, while parameters such as weight (in kilograms), head circumference (in cm), and height (in cm) will be assessed for growth monitoring over a 7-day period. The data obtained will be used to evaluate the babies' feeding.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start5 Jul 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Newborn PretermStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Sonmez Duzkaya, Tarsus University
- Investigators
- Tarsus University, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079878
- Sponsor's protocol ID
- 2024/62
- Status last verified
- Jul 2025
- First submitted
- 10 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Özkan, H. (2016). Preterm ve Term Yenidoğanda Büyümenin Değerlendirilmesi. Klinik Tıp Pediatri Dergisi, 83-87.
Özge Karakaya Suzan, N. Ç. (2020). Kolostrum: Özellikleri ve Prematüre Bebeğe Faydaları. Sted, 221-227
Bozkurt, G., Sönmez Düzkaya D. (2015). Enteral Beslenme Uygulama Protokolü. Yenidoğan Protokolleri (s. 157-159). içinde İstanbul: Nobel Tıp Kitabevleri.
Demet Terek, M. Y. (2019). Yenidoğan Bebeğin Beslenmesinde Temel Prensipler. Klinik Tıp Pediatri Dergisi, 233-244.
Aysel Gürkan, B. G. (2013). Enteral Beslenme: Bakımda Güncel Yaklaşımlar Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 116-122
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bed Head Height During Feeding With Orogastric Catheter on Neonatal Growth Parameters and Feeding Tolerance in Preterm Newborns
- ClinicalTrials.gov ID
- NCT07079878
- Acronym / sponsor ID
- 2024/62
- Conditions
- Newborn Preterm
- Keywords
- preterm, oragastrik beslenme, beslenme, pozisyon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 23 Jul 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.
Aim:The study was planned as a randomised controlled experimental study to determine the effect of bed head height applied during feeding with orogastric catheter on growth parameters and feeding tolerance of preterm newborns.
Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 newbornMethod: The study was a randomised controlled experimental study. The sample of the study consisted of 96 preterm newborns (control: 32, Group with 30° Bed Head Height: 32, Group with 45° Bed Head Height: 32) ). Data Collection Form was used as a data collection tool. The head of the newborns in the intervention group will be raised before the orogastric catheter is inserted, and the children in the control group will be routinely positioned. In this process, physiological parameters of newborns before and after positioning will be followed.
Detailed description
The population of the study, which is planned as a prospective randomised controlled experimental study, will consist of preterm newborns hospitalised in the Neonatal Intensive Care Unit of Mersin City Hospital. While determining the sample size of the study, the scientific study titled 'Effects of the prone position and kangaroo care on gastric residual volume, vital signs and comfort in preterm infants' by Özdel \& Sarı (2020) was taken as a basis as a result of literature reviews in order to determine the effect size sample size. As a result of the Power analysis (G*Power 3.1.9.2) performed according to Özdel \& Sarı (2020) study; effect size = 0.967, 95% confidence interval, 95% power, it was calculated that a total of 87 newborns, at least 29 in each group, should be included. Considering the possibility of drop outs and confounding variables in the research process, the number in the groups was increased by 10%. The sample of the study was determined as 96 newborns in total, 32 newborns in each group. Randomisation In the study, 96 children in the sample will be randomly assigned to the control group, the 1st study group (Group with 30° Bed Head Height) and the 2nd study group (Group with 45° Bed Head Height). Random assignment will be made using a computer programme to determine the group of children (https://www.randomlists.com/team-generator).Place and Time of the Study The study will be conducted between July 2024 and March 2025 in the Neonatal Intensive Care Unit of Mersin City Hospital. Mersin City Hospital Obstetrics and Gynaecology Department has 2 Neonatal Intensive Care Units on the 2nd floor and 3rd floor. Research 2nd floor. In the Neonatal Intensive Care Unit, 2nd step and 3rd step patients are cared for. There are 30 incubators in the unit. Newborns with prematurity, congenital anomalies, respiratory distress, maternal preeclampsia, maternal diabetes mellitus, hypoglycaemia, and Exchange borderline phototherapy need are admitted to the Neonatal Intensive Care Unit.Data CollectionIn the study, preterm newborns who are fed with orogastric catheter in the Neonatal Intensive Care Unit will first be evaluated in terms of sampling criteria, and newborns who do not meet the criteria will be excluded from the study. The nurse who collects the data and assesses vital signs and nutritional tolerance will be the investigator herself (Nurse Özlem BORAK). Feeding of the newborns in all groups will be done in accordance with the 'Enteral Nutrition Protocol': Before starting the study, nurses working in the clinic will be trained in enteral nutrition in accordance with the 'Enteral Nutrition Protocol'.2: After obtaining written consent from the parent of the preterm baby to be fed with orogastric catheter, the application of feeding with orogastric catheter and what to be done during the procedure will be explained to the parent. Then, the newborn information form will be filled out.Stage 3: After the groups are determined in accordance with the randomisation table, the necessary materials are prepared in accordance with the feeding protocol. Stage 4: 30 minutes before feeding, the bed head height will be adjusted appropriately.5: The vital signs of the newborn (fever, pulse, respiration, oxygen saturation) will be measured 30 minutes before feeding.6: Feeding will be applied at a height of 15-20 cm, without applying pressure, at its own flow rate in 20 minutes. Stage 7: Vital signs (fever, pulse, respiration, oxygen saturation) will be measured during and 30 minutes after feeding. Stage 8: Abdominal distension will be evaluated before and 2 hours after feeding to assess nutritional tolerance. Abdominal circumference will be measured at the same time every day. Vomiting will be monitored after feeding.9: When evaluating growth parameters, weight monitoring, head circumference and height parameters will be evaluated. Weight will be monitored every day. Head circumference and height will be evaluated on the 1st and 7th days.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group with Bed Head Height 30° | Experimental | Other: Group with Bed Head Height 30°In the preterm newborn lying in the neonatal intensive care unit, the bed head height is adjusted to 30° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form. |
| Group with Bed Head Height 45° | Experimental | Other: Group with Bed Head Height 45°The head of the bed of the preterm newborn lying in the neonatal intensive care unit is adjusted to 45° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form. |
| Control Group | No intervention | –The bed head height of the preterm newborn lying in the neonatal intensive care unit is adjusted in accordance with the clinical routine (15°) and vital signs are monitored 30 minutes before feeding. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. All data will be evaluated by the investigator and recorded on the intervention monitoring form. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The newborn should be in the 32-36th postnatal week
- The weight of the newborn should be over 1500 grams
- The newborn should be able to meet at least 75% of the protein and energy amount that he/she should take through the enteral route
- The newborn should be fed with an orogastric catheter
- The newborn should not need a mechanical ventilator
Key exclusion criteria (5 listed)
- Neonates with NEC
- Newborns whose bedhead height cannot be provided due to any condition
- Previous findings of feeding intolerance
- Having a chest tube
- Parents not volunteering to participate in the study
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 |
|---|---|---|
| Group with Bed Head Height 30°30 minutes before feeding, the bed head height of the preterm newborn is adjusted to 30° and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. | Other | Group with Bed Head Height 30° |
| Group with Bed Head Height 45°The bed head height of the preterm newborn is adjusted to 45° 30 minutes before feeding and vital signs are monitored. After 30 minutes, the newborn is fed and vital signs are monitored during feeding. The vital signs are monitored again 30 minutes after feeding. While evaluating nutritional tolerance, abdominal distension, abdominal circumference measurement and vomiting are monitored. Growth parameters of the newborn are recorded on the growth monitoring form for 7 days. | Other | Group with Bed Head Height 45° |
Primary outcome
Newborn Information Form
Time frame: 1 day
The information form was prepared by reviewing the relevant literature (Özdel, 2017). The neonatal information form includes 14 items including mode of delivery, 1st and 5th minute APGAR score, gestational age, birth weight, birth weight, birth head circumference, birth length, gender, mother's history of any disease during pregnancy, hospitalisation diagnosis, postnatal age, weight, height and head circumference at the time of assessment.This form will be used to identify the newborn. The average values will be calculated based on age (in days), weight (in kg), and height (in cm).
Newborn Monitoring Form
Time frame: 1 day
The follow-up form was prepared based on a review of the relevant literature (Özdel, 2017; Yüce 2020). In the newborn follow-up form, vital signs such as body temperature (Celsius), heart rate (beats per minute), respiratory rate (breaths per minute) and oxygen saturation (percentage) will be measured in the morning and evening for 7 days, and abdominal distension, abdominal circumference measurement (cm), and vomiting status will be assessed in terms of feeding tolerance, while parameters such as weight (in kilograms), head circumference (in cm), and height (in cm) will be assessed for growth monitoring over a 7-day period. The data obtained will be used to evaluate the babies' 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 23 Jul 2025.
- Results publicationÖzkan, H. (2016). Preterm ve Term Yenidoğanda Büyümenin Değerlendirilmesi. Klinik Tıp Pediatri Dergisi, 83-87.
- Results publicationÖzge Karakaya Suzan, N. Ç. (2020). Kolostrum: Özellikleri ve Prematüre Bebeğe Faydaları. Sted, 221-227
- Results publicationBozkurt, G., Sönmez Düzkaya D. (2015). Enteral Beslenme Uygulama Protokolü. Yenidoğan Protokolleri (s. 157-159). içinde İstanbul: Nobel Tıp Kitabevleri.
- Results publicationDemet Terek, M. Y. (2019). Yenidoğan Bebeğin Beslenmesinde Temel Prensipler. Klinik Tıp Pediatri Dergisi, 233-244.
- Results publicationAysel Gürkan, B. G. (2013). Enteral Beslenme: Bakımda Güncel Yaklaşımlar Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 116-122
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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.
Tarsus University principal investigator
Tarsus 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 Group with Bed Head Height 30° and Group with Bed Head Height 45° in people with Newborn Preterm, run by Tarsus 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 7 inclusion and 5 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 23 Jul 2025. 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?
Newborn Information Form (time frame: 1 day). 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?
On the ClinicalTrials.gov record for NCT07079878, which also lists 5 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 23 Jul 2025.