Feeding Intolerance in Preterm Infant

Feeding Intolerance in Preterm Infant ,Rate of Occurrences, Risk Factors , Outcomes

To determine the incidence and risk factors of feeding intolerance in preterm infants. To assess the outcome of feeding intolerance in preterm infants.

Study Overview

• Status: Not yet recruiting
• Conditions: Feeding Intolernce

Detailed Description

Premature infants frequently suffer from feeding intolerance related to prematurity and are highly associated with morbidity and mortality. [1] Feeding intolerance (FI) is defined as difficulty to digest enteral feedings and is accompanied by an increase in gastric residuals, abdominal distension, and/or reflux. It is common in preterm infants and commonly results in feeding and gastrointestinal disruptions. FI in newborns can be a sign of a variety of problems, ranging from minor, self-limiting illnesses to serious, life-threatening illnesses. [2] The common cause of FI is low intestinal motility because of prematurity , Enzymatic digestion, bacterial colonization, hormonal response, and local immunity are also possible reasons for FI. [3] FI is very common among preterm infants and its clinical symptoms include abdominal distension, vomiting, bilious gastric residuals, occult or gross bloody stools, and are observed in nearly 29% of such neonates. [4] Factors that contribute to feeding intolerance include poor coordination of sucking and swallowing, incompetent lower esophageal sphincter, small gastric capacity, delayed gastric emptying time, and intestinal hypomotility. Abnormal bacterial colonization may be a coexisting factor in feeding intolerance in newborns mainly due to dysfunction of the intestinal barrier, the immune responses, and sensory motor functions of the gut. [5] Mother's milk feeding is related to better feeding tolerance and may be correlated to a reduction in severe morbidity. [6] The mode of delivery (vaginal or cesarean section) and feeding type (breastfeeding or formula feeding) of neonates are considered the most influential factors in the development of gut microbiota. [7] In the preterm infant, the readiness to tolerate enteral nutrition relies upon the degree of maturation of gastro-intestinal (G-I) functions (motility, enzymatic digestion, hormonal responses, bacterial colonization and local immunity). Anatomical development of the GI tract is largely completed at 20 weeks of gestation, although the elongation of the GI tube and increases in the absorbing area (microvilli) continue during the last trimester of gestation and beyond. [8] Successful establishment of enteral feedings is a major goal in the treatment of very low-birthweight infants, but functional immaturity of the gastrointestinal tract may hamper such efforts. Prokinetic agents often are used in an attempt to overcome functional immaturity by speeding up gastric empyting and increase intestinal wall motility.[9]

• Study Type: Observational
• Enrollment (Estimated): 63

Contacts and Locations

• Study Contact: Name: Hager Amer Abdelaziz, Bachelor of medicine; Phone Number: 01023762165; Email: amerhager941@gmail.com
• Study Contact Backup: Name: Gafar Ibrahim Mohamed, Professor; Phone Number: 01020627864; Email: Gafar.ibrahim@med.au.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Preterm infants less than 37 weeks

Description

Inclusion Criteria:

• Preterm infants (gestational age < 37 weeks).
• Preterm infants from day 0 to day 28 of life.

Exclusion Criteria:

• We will exclude those babies:
• Full-term babies (gestational age > 37 weeks).
• Preterm babies with gastrointestinal anomalies.
• Preterm babies with suspected inborn errors of metabolism.
• Preterm babies with suspected necrotizing enterocolitis and sepsis at the onset of feeding.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the incidence and risk factors of feeding intolerance in preterm infants. To assess the outcome of feeding intolerance in preterm infants	To determine the incidence and risk factors of feeding intolerance in preterm infants.by assessment of extremely low birth with congenital heart disease by echo , Respiratory distress syndrome by chest x ray In order to determine : A_ Daily weight gain by BMI B_ Days to reach fulfill feeding C_ Duration of hospital stay.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Ford SL, Lohmann P, Preidis GA, Gordon PS, O'Donnell A, Hagan J, Venkatachalam A, Balderas M, Luna RA, Hair AB. Improved feeding tolerance and growth are linked to increased gut microbial community diversity in very-low-birth-weight infants fed mother's own milk compared with donor breast milk. Am J Clin Nutr. 2019 Apr 1;109(4):1088-1097. doi: 10.1093/ajcn/nqz006.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Feeding intolernce

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No