Nasogastric TubeNCT06765720
Effects of Intermittent Feeding Methods With Nasogastric and Orogastric Tubes in Preterm Infants
A study testing Intermittent feeding method with nasogastric tube and Intermittent feeding method with orogastric tube in people with Nasogastric Tube and Orogastric Tube, run by İstanbul Yeni Yüzyıl Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
The study is a randomized controlled, prospective, double-blind trial planned to compare the effects of intermittent feeding methods using nasogastric and orogastric tubes on the growth, nutrition, and physiological parameters of preterm infants. Read more about this study
- Who is it for?
- Ages 30 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Nasogastric Tube, Orogastric Tube
- What is being tested?
- Intermittent feeding method with nasogastric tube and Intermittent feeding method with orogastric tube
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Nov 2025
- 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 30 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants with a gestational age of ≥30 weeks at birth, determined according to the mother's last menstrual period, and appropriate for gestational age,
- Postmenstrual age of ≥30 weeks at the time of inclusion in the study,
- Recommended for enteral feeding by a neonatologist,
- Infants starting enteral feeding for the first time and fed at three-hour intervals using gravity-assisted nasogastric or orogastric tubes,
- Infants who have not undergone oral feeding trials,
- Infants who have not received any oral motor interventions,
- Infants whose parents have given consent for inclusion in the study and signed an informed consent form after being provided with detailed information.
Who cannot join
- Infants receiving mechanical ventilation support during the study,
- Infants with an umbilical catheter,
- Infants who received intubation, CPAP, or nasal prong oxygen support for more than 14 days before inclusion in the study,
- Infants with craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis,
- Infants with any gastrointestinal, neurological, or chromosomal disease (e.g., necrotizing enterocolitis, grade III and IV intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, Down syndrome, and other diseases),
- Infants with severe bronchopulmonary dysplasia according to the criteria of Jobe and Bancalari (2001) or requiring surgical treatment for patent ductus arteriosus.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeni Yüzyıl University
Zeytinburnu, Istanbul, 34010
About this study
Official title: The Comparison of the Effects of Intermittent Feeding Methods With Nasogastric and Orogastric Tubes on Growth, Nutrition, and Physiological Parameters in Preterm Infants: A Randomized Controlled Trial
The study is a randomized controlled, prospective, double-blind trial planned to compare the effects of intermittent feeding methods using nasogastric and orogastric tubes on the growth, nutrition, and physiological parameters of preterm infants.
The population of the study will consist of preterm infants admitted to the Neonatal Intensive Care Unit of a public hospital in Istanbul between February and December 2025. The sample will include 60 preterm infants who meet the research criteria and whose parents agree to participate in the study.
Read more
Through randomization, preterm infants will be assigned to either the nasogastric tube group (experimental) or the orogastric tube group (control) from their first enteral feeding until the transition to full oral feeding is completed.
Data for preterm infants in both groups will be collected using the "Preterm Infant Information Form, Early Feeding Skills Assessment Tool, and Nutrition Monitoring Form," which were developed by the researchers based on literature information and expert opinions. These data will encompass growth, nutrition, and physiological parameters before, during, and after feeding throughout the study.
Hypotheses of the Study
H0: There is no significant difference in the effects of intermittent feeding methods using nasogastric and orogastric tubes on growth, feeding complications, and physiological parameters in preterm infants.
H1: There is a significant difference between intermittent feeding methods using nasogastric and orogastric tubes in preterm infants in terms of growth parameters (daily weight gain in grams, time to regain birth weight, time to transition to full enteral feeding, time to transition to full oral feeding, and Early Feeding Skills Assessment Tool score).
H1(1): Preterm infants fed with a nasogastric tube have greater daily weight gain (grams) compared to those fed with an orogastric tube.
H1(2): The time to regain birth weight (days) in preterm infants fed with a nasogastric tube is shorter compared to those fed with an orogastric tube.
H1(3): The time to transition to full enteral feeding (days) in preterm infants fed with a nasogastric tube is shorter compared to those fed with an orogastric tube.
H1(4): The time to transition to full oral feeding (days) in preterm infants fed with a nasogastric tube is shorter compared to those fed with an orogastric tube.
H1(5): The Early Feeding Skills Assessment Tool score of preterm infants fed with a nasogastric tube is higher compared to those fed with an orogastric tube.
H2: There is a significant difference between intermittent feeding methods using nasogastric and orogastric tubes in preterm infants in terms of feeding complications (tube replacement, mucosal trauma, and feeding intolerance).
H2(1): The frequency of tube replacement in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
H2(2): The incidence of mucosal trauma in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
H2(3): The incidence of feeding intolerance in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
H3: There is a significant difference between intermittent feeding methods using nasogastric and orogastric tubes in preterm infants in terms of physiological parameters (oxygen saturation, heart rate, and apnea).
H3(1): The oxygen saturation levels during and after feeding in preterm infants fed with a nasogastric tube are higher compared to those fed with an orogastric tube.
H3(2): The heart rate during and after feeding in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
H3(3): The incidence of apnea in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
Read the detailed description
Enteral feeding is preferred as a safe method for preterm infants whose oral feeding skills have not yet developed or who are not ready for oral feeding. It is also implemented to support intestinal development and avoid the long-term side effects of parenteral nutrition. Enteral feeding is a method that allows infants to receive nutrients by utilizing the natural functions of their gastrointestinal system through the advancement of a feeding tube from the mouth or nose to the stomach. Feeding via nasogastric and orogastric tube methods, commonly used in neonatal intensive care units, provides enteral nutrition support for preterm infants. The nasogastric tube is inserted through the nose into the stomach, while the orogastric tube is placed through the mouth into the stomach. Both feeding methods offer various advantages and disadvantages based on the individual needs and clinical conditions of the infants. Therefore, the selection of the feeding method should involve a comprehensive evaluation of the potential benefits and risks unique to each method for the infant.
Since preterm infants breathe nasally, feeding with a nasogastric tube can cause partial nasal obstruction, leading to increased airway resistance and respiratory workload. This situation may result in the collapse of the pharyngeal airways and an increased incidence of apnea of prematurity in preterm infants. Additionally, prolonged feeding with a nasogastric tube in preterm infants has been reported to cause nasal septum defects. In contrast, while the placement and fixation of orogastric tubes are generally easier, these tubes can lead to complications such as displacement or incorrect placement into the lungs, aspiration, increased respiratory resistance, and bradycardia episodes due to vagal stimulation. Furthermore, the prolonged use of orogastric tubes in very low birth weight preterm infants may increase the risk of palate deformation. Therefore, the selection of the feeding method should be based on the infant's health status, respiratory functions, and other clinical parameters.
In the literature, studies investigating the effects of nasogastric and orogastric tubes on preterm infants have shown that the sample groups are limited, crossover designs were used, and there are methodological limitations regarding the determination of evaluation parameters and the process of transition to full enteral feeding. It has been observed that there is a need for a randomized controlled study with a large sample size to examine the effects of intermittent feeding methods using nasogastric and orogastric tubes on the growth, nutrition, and physiological parameters of preterm infants. Accordingly, this research was planned as a randomized controlled, prospective, double-blind study to compare the effects of intermittent feeding methods using nasogastric and orogastric tubes on the growth, nutrition, and physiological parameters of preterm infants.
The infants to be included in the study will be selected according to the determined inclusion criteria and then randomly divided into two groups: nasogastric tube feeding group and orogastric tube feeding group.
In the study, the randomization process will be carried out using the urn method. The urn method is equivalent to complete randomization and will be expressed with two parameters, α and β. These parameters will be symbolized as balls in red and white colors. White or red color will represent α; β will represent the opposite color of α. In each assignment process, the color of a randomly selected ball will determine which group the infant will be assigned to: when a white ball is selected, the infant will be assigned to the orogastric group, and when a red ball is selected, the infant will be assigned to the nazogastric group. In the study, the white ball will be designated as the orogastric group, and the red ball will be designated as the nazogastric group. For each new infant participant who meets the sample criteria, the previously prepared balls will be stored in a black bag, and a nurse on duty in the unit will randomly select one with their eyes closed. Based on the color of the selected ball, infants will be assigned to the groups, ensuring a random distribution between groups
- Conditions
- Nasogastric Tube, Orogastric Tube
- Being tested
- Intermittent feeding method with nasogastric tube, Intermittent feeding method with orogastric tube
- Keywords
- intermittent feeding, enteral feeding, nasogastric tube, orogastric tube, preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent feeding method with nasogastric tubeOther
30 Minutes Before Feeding: No invasive procedures will be performed 30 minutes before the daily 1:00 PM feeding.
5 Minutes Before Feeding: To measure physiological variables, the pulse oximeter probe will be attached to the baby's foot. Oxygen saturation and heart rate will be measured for 2 minutes before feeding.
Feeding Phase: Measurement values will be taken from the pulse oximeter during feeding.
Post-Feeding Phase: Any interventions that could affect physiological values will be prevented, and oxygen saturation and heart rate will continue to be measured during the 2-minute period. The baby will be scored using the Early Feeding Skills Assessment Tool.
Intermittent feeding method with orogastric tubeOther
30 Minutes Before Feeding: No invasive procedures will be performed 30 minutes before the daily 1:00 PM feeding.
5 Minutes Before Feeding: To measure physiological variables, the pulse oximeter probe will be attached to the baby's foot. Oxygen saturation and heart rate will be measured for 2 minutes before feeding.
Feeding Phase: Measurement values will be taken from the pulse oximeter during feeding.
Post-Feeding Phase: Any interventions that could affect physiological values will be prevented, and oxygen saturation and heart rate will continue to be measured during the 2-minute period. The baby will be scored using the Early Feeding Skills Assessment Tool.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent feeding method with nasogastric tube | Experimental | Preterm infants in this group will be fed via a nasogastric tube during the transition period from the initiation of enteral feeding to full oral feeding. Receives: Other: Intermittent feeding method with nasogastric tube |
| Intermittent feeding method with orogastric tube | Experimental | Preterm infants in this group will be fed via a orogastric tube during the transition period from the initiation of enteral feeding to full oral feeding. Receives: Other: Intermittent feeding method with orogastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to transition to full enteral feeding
An infant will be considered to have transitioned to full enteral feeding once all energy and nutrient needs are met for 48 hours through intermittent enteral feeding eight times a day at three-hour intervals.
Measured: From the infant's birth until the time they achieve full enteral feeding.Time frame is through study completion, an average of 8 months.
Time to transition to full oral feeding
An infant will be considered to have achieved full oral feeding once they can take 8 feedings per day orally at three-hour intervals for 48 hours and gain 20-30 g/kg.
Measured: From the infant's birth until the time they achieve full oral feeding.Time frame is through study completion, an average of 8 months.
Time to regain birth weight
Measured: The number of days it takes for them to recover the weight they lost after birth.Time frame is through study completion, an average of 8 months.
Daily weight gain
Measured: It will be measured every day throughout the research. Time frame is through study completion, an average of 8 months.
Early Feeding Skills Assessment Tool score
Measured: It will be evaluated every day throughout the research.Time frame is through study completion, an average of 8 months.
Secondary outcomes (6)
Frequency of tube changes
Measured: It will be evaluated every day throughout the research.Time frame is through study completion, an average of 8 months.
Incidence of mucosal trauma
Measured: It will be evaluated every day throughout the research.Time frame is through study completion, an average of 8 months.
Development and frequency of feeding intolerance
Measured: Time frame is through study completion, an average of 8 months.
Oxygen saturation levels
Measured: Time frame is through study completion, an average of 8 months.
Heart rate variability
Measured: Time frame is through study completion, an average of 8 months.
Incidence of apnea
Measured: Time frame is through study completion, an average of 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Mar 2025
- Primary completion1 Jul 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasogastric TubeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- İstanbul Yeni Yüzyıl Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Çarıkçı, İstanbul Yeni Yüzyıl Üniversitesi
- Investigators
- Burcu Aykanat Girgin, Assoc. Dr., Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765720
- Sponsor's protocol ID
- 20212024BAG-FC
- Status last verified
- Nov 2026
- First submitted
- 26 Dec 2024
- Last updated
- 5 Nov 2026
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effects of Intermittent Feeding Methods With Nasogastric and Orogastric Tubes on Growth, Nutrition, and Physiological Parameters in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06765720
- Acronym / sponsor ID
- 20212024BAG-FC
- Conditions
- Nasogastric Tube, Orogastric Tube
- Keywords
- intermittent feeding, enteral feeding, nasogastric tube, orogastric tube, preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- İstanbul Yeni Yüzyıl ÜniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized controlled, prospective, double-blind trial planned to compare the effects of intermittent feeding methods using nasogastric and orogastric tubes on the growth, nutrition, and physiological parameters of preterm infants.
The population of the study will consist of preterm infants admitted to the Neonatal Intensive Care Unit of a public hospital in Istanbul between February and December 2025. The sample will include 60 preterm infants who meet the research criteria and whose parents agree to participate in the study.
Through randomization, preterm infants will be assigned to either the nasogastric tube group (experimental) or the orogastric tube group (control) from their first enteral feeding until the transition to full oral feeding is completed.
Data for preterm infants in both groups will be collected using the "Preterm Infant Information Form, Early Feeding Skills Assessment Tool, and Nutrition Monitoring Form," which were developed by the researchers based on literature information and expert opinions. These data will encompass growth, nutrition, and physiological parameters before, during, and after feeding throughout the study.
Hypotheses of the Study
H0: There is no significant difference in the effects of intermittent feeding methods using nasogastric and orogastric tubes on growth, feeding complications, and physiological parameters in preterm infants.
H1: There is a significant difference between intermittent feeding methods using nasogastric and orogastric tubes in preterm infants in terms of growth parameters (daily weight gain in grams, time to regain birth weight, time to transition to full enteral feeding, time to transition to full oral feeding, and Early Feeding Skills Assessment Tool score).
H1(1): Preterm infants fed with a nasogastric tube have greater daily weight gain (grams) compared to those fed with an orogastric tube.
H1(2): The time to regain birth weight (days) in preterm infants fed with a nasogastric tube is shorter compared to those fed with an orogastric tube.
H1(3): The time to transition to full enteral feeding (days) in preterm infants fed with a nasogastric tube is shorter compared to those fed with an orogastric tube.
H1(4): The time to transition to full oral feeding (days) in preterm infants fed with a nasogastric tube is shorter compared to those fed with an orogastric tube.
H1(5): The Early Feeding Skills Assessment Tool score of preterm infants fed with a nasogastric tube is higher compared to those fed with an orogastric tube.
H2: There is a significant difference between intermittent feeding methods using nasogastric and orogastric tubes in preterm infants in terms of feeding complications (tube replacement, mucosal trauma, and feeding intolerance).
H2(1): The frequency of tube replacement in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
H2(2): The incidence of mucosal trauma in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
H2(3): The incidence of feeding intolerance in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
H3: There is a significant difference between intermittent feeding methods using nasogastric and orogastric tubes in preterm infants in terms of physiological parameters (oxygen saturation, heart rate, and apnea).
H3(1): The oxygen saturation levels during and after feeding in preterm infants fed with a nasogastric tube are higher compared to those fed with an orogastric tube.
H3(2): The heart rate during and after feeding in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
H3(3): The incidence of apnea in preterm infants fed with a nasogastric tube is lower compared to those fed with an orogastric tube.
Detailed description
Enteral feeding is preferred as a safe method for preterm infants whose oral feeding skills have not yet developed or who are not ready for oral feeding. It is also implemented to support intestinal development and avoid the long-term side effects of parenteral nutrition. Enteral feeding is a method that allows infants to receive nutrients by utilizing the natural functions of their gastrointestinal system through the advancement of a feeding tube from the mouth or nose to the stomach. Feeding via nasogastric and orogastric tube methods, commonly used in neonatal intensive care units, provides enteral nutrition support for preterm infants. The nasogastric tube is inserted through the nose into the stomach, while the orogastric tube is placed through the mouth into the stomach. Both feeding methods offer various advantages and disadvantages based on the individual needs and clinical conditions of the infants. Therefore, the selection of the feeding method should involve a comprehensive evaluation of the potential benefits and risks unique to each method for the infant.
Since preterm infants breathe nasally, feeding with a nasogastric tube can cause partial nasal obstruction, leading to increased airway resistance and respiratory workload. This situation may result in the collapse of the pharyngeal airways and an increased incidence of apnea of prematurity in preterm infants. Additionally, prolonged feeding with a nasogastric tube in preterm infants has been reported to cause nasal septum defects. In contrast, while the placement and fixation of orogastric tubes are generally easier, these tubes can lead to complications such as displacement or incorrect placement into the lungs, aspiration, increased respiratory resistance, and bradycardia episodes due to vagal stimulation. Furthermore, the prolonged use of orogastric tubes in very low birth weight preterm infants may increase the risk of palate deformation. Therefore, the selection of the feeding method should be based on the infant's health status, respiratory functions, and other clinical parameters.
In the literature, studies investigating the effects of nasogastric and orogastric tubes on preterm infants have shown that the sample groups are limited, crossover designs were used, and there are methodological limitations regarding the determination of evaluation parameters and the process of transition to full enteral feeding. It has been observed that there is a need for a randomized controlled study with a large sample size to examine the effects of intermittent feeding methods using nasogastric and orogastric tubes on the growth, nutrition, and physiological parameters of preterm infants. Accordingly, this research was planned as a randomized controlled, prospective, double-blind study to compare the effects of intermittent feeding methods using nasogastric and orogastric tubes on the growth, nutrition, and physiological parameters of preterm infants.
The infants to be included in the study will be selected according to the determined inclusion criteria and then randomly divided into two groups: nasogastric tube feeding group and orogastric tube feeding group.
In the study, the randomization process will be carried out using the urn method. The urn method is equivalent to complete randomization and will be expressed with two parameters, α and β. These parameters will be symbolized as balls in red and white colors. White or red color will represent α; β will represent the opposite color of α. In each assignment process, the color of a randomly selected ball will determine which group the infant will be assigned to: when a white ball is selected, the infant will be assigned to the orogastric group, and when a red ball is selected, the infant will be assigned to the nazogastric group. In the study, the white ball will be designated as the orogastric group, and the red ball will be designated as the nazogastric group. For each new infant participant who meets the sample criteria, the previously prepared balls will be stored in a black bag, and a nurse on duty in the unit will randomly select one with their eyes closed. Based on the color of the selected ball, infants will be assigned to the groups, ensuring a random distribution between groups
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent feeding method with nasogastric tube | Experimental | Other: Intermittent feeding method with nasogastric tubePreterm infants in this group will be fed via a nasogastric tube during the transition period from the initiation of enteral feeding to full oral feeding. |
| Intermittent feeding method with orogastric tube | Experimental | Other: Intermittent feeding method with orogastric tubePreterm infants in this group will be fed via a orogastric tube during the transition period from the initiation of enteral feeding to full oral feeding. |
Who may qualify
- Ages
- 30 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Preterm infants with a gestational age of ≥30 weeks at birth, determined according to the mother's last menstrual period, and appropriate for gestational age,
- Postmenstrual age of ≥30 weeks at the time of inclusion in the study,
- Recommended for enteral feeding by a neonatologist,
- Infants starting enteral feeding for the first time and fed at three-hour intervals using gravity-assisted nasogastric or orogastric tubes,
- Infants who have not undergone oral feeding trials,
Key exclusion criteria (6 listed)
- Infants receiving mechanical ventilation support during the study,
- Infants with an umbilical catheter,
- Infants who received intubation, CPAP, or nasal prong oxygen support for more than 14 days before inclusion in the study,
- Infants with craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis,
- Infants with any gastrointestinal, neurological, or chromosomal disease (e.g., necrotizing enterocolitis, grade III and IV intracranial hemorrhage, periventricular leukomalacia, hydrocephalus, Down syndrome, and other diseases),
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 |
|---|---|---|
| Intermittent feeding method with nasogastric tube30 Minutes Before Feeding: No invasive procedures will be performed 30 minutes before the daily 1:00 PM feeding. 5 Minutes Before Feeding: To measure physiological variables, the pulse oximeter probe will be attached to the baby's foot. Oxygen saturation and heart rate will be measured for 2 minutes before feeding. Feeding Phase: Measurement values will be taken from the pulse oximeter during feeding. Post-Feeding Phase: Any interventions that could affect physiological values will be prevented, and oxygen saturation and heart rate will continue to be measured during the 2-minute period. The baby will be scored using the Early Feeding Skills Assessment Tool. | Other | Intermittent feeding method with nasogastric tube |
| Intermittent feeding method with orogastric tube30 Minutes Before Feeding: No invasive procedures will be performed 30 minutes before the daily 1:00 PM feeding. 5 Minutes Before Feeding: To measure physiological variables, the pulse oximeter probe will be attached to the baby's foot. Oxygen saturation and heart rate will be measured for 2 minutes before feeding. Feeding Phase: Measurement values will be taken from the pulse oximeter during feeding. Post-Feeding Phase: Any interventions that could affect physiological values will be prevented, and oxygen saturation and heart rate will continue to be measured during the 2-minute period. The baby will be scored using the Early Feeding Skills Assessment Tool. | Other | Intermittent feeding method with orogastric tube |
Primary outcome
Time to transition to full enteral feeding
Time frame: From the infant's birth until the time they achieve full enteral feeding.Time frame is through study completion, an average of 8 months.
An infant will be considered to have transitioned to full enteral feeding once all energy and nutrient needs are met for 48 hours through intermittent enteral feeding eight times a day at three-hour intervals.
Time to transition to full oral feeding
Time frame: From the infant's birth until the time they achieve full oral feeding.Time frame is through study completion, an average of 8 months.
An infant will be considered to have achieved full oral feeding once they can take 8 feedings per day orally at three-hour intervals for 48 hours and gain 20-30 g/kg.
Time to regain birth weight
Time frame: The number of days it takes for them to recover the weight they lost after birth.Time frame is through study completion, an average of 8 months.
Daily weight gain
Time frame: It will be measured every day throughout the research. Time frame is through study completion, an average of 8 months.
Early Feeding Skills Assessment Tool score
Time frame: It will be evaluated every day throughout the research.Time frame is through study completion, an average of 8 months.
6 secondary outcomes
Frequency of tube changes
Time frame: It will be evaluated every day throughout the research.Time frame is through study completion, an average of 8 months.
Incidence of mucosal trauma
Time frame: It will be evaluated every day throughout the research.Time frame is through study completion, an average of 8 months.
Development and frequency of feeding intolerance
Time frame: Time frame is through study completion, an average of 8 months.
Oxygen saturation levels
Time frame: Time frame is through study completion, an average of 8 months.
Heart rate variability
Time frame: Time frame is through study completion, an average of 8 months.
Incidence of apnea
Time frame: Time frame is through study completion, an average of 8 months.
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 5 Nov 2026.
- 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.
Burcu Aykanat Girgin, Assoc. Dr. study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent feeding method with nasogastric tube and Intermittent feeding method with orogastric tube in people with Nasogastric Tube and Orogastric Tube, run by İstanbul Yeni Yüzyıl Üniversitesi 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 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 5 Nov 2026. 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?
Time to transition to full enteral feeding (time frame: From the infant's birth until the time they achieve full enteral feeding.Time frame is through study completion, an average of 8 months.). The study lists 5 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 5 Nov 2026.