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Feeding IntolernceNCT06693557

Feeding Intolerance in Preterm Infant

An observational study of Feeding Intolernce, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To determine the incidence and risk factors of feeding intolerance in preterm infants. To assess the outcome of feeding intolerance in preterm infants. Read more about this study

Who is it for?
Ages 1 week to 36 weeksHealthy volunteers can take part
Conditions the study is for
Feeding Intolernce
How many people
63 participants
Where
No sites listed yet
Study dates
1 Jan 2025to 30 Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 week to 36 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Preterm infants less than 37 weeks

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hager Amer Abdelaziz, Bachelor of medicine contact

01023762165

amerhager941@gmail.com

Gafar Ibrahim Mohamed, Professor contact

01020627864

Gafar.ibrahim@med.au.edu.eg

About this study

Official title: 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.

Read the 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]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06693557
Sponsor's protocol ID
Feeding intolernce
Status last verified
Nov 2024
First submitted
13 Nov 2024
Last updated
18 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 30982856

Questions about this trial

What is this clinical trial studying?

An observational study of Feeding Intolernce, run by Assiut University.

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 2 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: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hager Amer Abdelaziz, Bachelor of medicine (01023762165, amerhager941@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the incidence and risk factors of feeding intolerance in preterm infants. To assess the outcome of feeding intolerance in preterm infants (time frame: Baseline). 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 NCT06693557, which also lists 1 linked publication.

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 18 Nov 2024.

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