Effects of Intermittent Feeding Methods With Nasogastric and Orogastric Tubes in Preterm Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-36
Sponsorİstanbul Yeni Yüzyıl Üniversitesi
About this 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.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent feeding method with nasogastric tube
Other intervention30 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 tube
Other intervention30 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intermittent feeding method with nasogastric tubeExperimental treatment 1 intervention
Group B: Intermittent feeding method with orogastric tubeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.2
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.
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.3
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.4
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.Secondary outcomes
1
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.2
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.3
Development and frequency of feeding intolerance
Time frame
Time frame is through study completion, an average of 8 months.4
Oxygen saturation levels
Time frame
Time frame is through study completion, an average of 8 months.Sponsors and contacts
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Source ClinicalTrials.gov
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