Effects of Intermittent Feeding Methods With Nasogastric and Orogastric Tubes in Preterm Infants

NCT06765720 | Not Yet Recruiting DMC

• 1 other identifier: 20212024BAG-FC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nasogastric Tube; Orogastric Tube

Keywords

intermittent feeding; enteral feeding; nasogastric tube; orogastric tube; preterm

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  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

  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

  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

  It will be evaluated every day throughout the research.Time frame is through study completion, an average of 8 months.

• Incidence of mucosal trauma

  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 is through study completion, an average of 8 months.

• Oxygen saturation levels

  Time frame is through study completion, an average of 8 months.

• Heart rate variability

  Time frame is through study completion, an average of 8 months.

Study Arms (2)

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.

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.

Other: Intermittent feeding method with orogastric tube

Interventions

Intermittent feeding method with nasogastric tube OTHER

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 nasogastric tube

Intermittent feeding method with orogastric tube OTHER

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 tube

Eligibility Criteria

• Age: 30 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• 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,

You may not qualify if:

• Infants receiving mechanical ventilation support during the study,
• Infants with an umbilical catheter,
• 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.

Sponsors & Collaborators

• İstanbul Yeni Yüzyıl Üniversitesi: lead

Study Sites (1)

Yeni Yüzyıl University

Zeytinburnu, Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Burcu Aykanat Girgin, Assoc. Dr.

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Central Study Contacts

Fatma Çarıkçı, PhD Student

CONTACT

+905355983492; fatma.carikci@yeniyuzyil.edu.tr

Burcu Aykanat Girgin, Assoc. Dr.

CONTACT

+905379200683; aykanat_87@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 9, 2025
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)