Amoxicillin for Enteral Nutrition Intolerance in Pediatric Intensive Care Unit
NCT ID: NCT05828758
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2023-04-24
2024-05-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Children with feeding intolerance will be randomized into study and comparison groups. The study group will receive amoxicillin 10 mg/kg by nasogastric tube 3 times daily 10 minutes before bolus gastric feeding for 7 days. The comparison group will receive equal volume of distilled water as a placebo.
The primary outcome will be the improvement of feeding intolerance on day 7 study timepoint.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of the Algorithm for Enteral Nutrition Support
NCT04609358
Feeding Children Nasogastrically Versus Nasojejunally While Receiving Noninvasive Positive Pressure Ventilation
NCT01301352
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
NCT04900597
Timing of Initiation of Parenteral Nutrition for Critically Ill Children
NCT04693143
Stepwise Enteral Nutritional Algorithm and Patient Outcomes in Pediatric Intensive Care Units
NCT07307027
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Enteral nutrition (EN) is the preferred route to administer nutritional support for critically ill children unless contraindicated. However, EN of critically ill children is challenging, and nutritional targets are commonly not attained.
EN intolerance (a clinical manifestation of delayed gastric emptying) is one of the main factors for limited delivery of enteral feeding. Promotility agents are commonly used as a first-line treatment for patients with EN intolerance. In critically ill adults, prokinetics have been shown to improve gastric emptying and enhance tolerance to gastric feeding. Available options include metoclopramide, domperidone, and erythromycin. However, there is insufficient evidence for recommending the use of prokinetics in children with critical illness to enhance gastric emptying and EN tolerance. Furthermore, currently available prokinetics are associated with serious side effects.
Amoxicillin/clavulanate combination is one of the most commonly prescribed antibiotics for children worldwide. Besides its antibacterial properties, some studies showed that amoxicillin/clavulanate could have prokinetic effects. However, well-designed randomized controlled trials to confirm the prokinetic effects of amoxicillin/clavulanate are lacking. Additionally, no human study has investigated the prokinetic effects of amoxicillin and clavulanate individually. In a study on juvenile rats, amoxicillin alone, but not clavulanate, was shown to increase the amplitude of spontaneous duodenal contractions. The use of amoxicillin alone rather than amoxicillin/clavulanate could have the advantages of avoiding the side effects of clavulanate, lowering the cost, and decreasing the risk of antibiotic resistance.
The goal of this randomized controlled study is to investigate the efficacy of enteral amoxicillin for the treatment of children with EN intolerance in PICU.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Study group: will receive amoxicillin 10 mg/kg (50 mg/ml concentration) by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days. The nasogastric tube will be flushed by 5 ml distilled water after each dose.
Control group: will receive equal volume of distilled water (0.2 ml/kg + 5 ml) as a placebo.
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study group
Children receiving amoxicillin
Amoxicillin
Amoxicillin 10 mg/kg (50 mg/ml concentration) by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.
Comparison group
Children receiving placebo
Placebo
Distilled water 0.2 ml/kg by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amoxicillin
Amoxicillin 10 mg/kg (50 mg/ml concentration) by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.
Placebo
Distilled water 0.2 ml/kg by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Nasogastric tube feeding
* Enteral nutrition intolerance after 7 days of admission to the PICU.
Exclusion Criteria
* Allergy or contraindication to amoxicillin or other beta-lactam antibiotics.
* Current or recent (within 7 days) treatment with amoxicillin.
* Ongoing ketogenic diet.
* Clinical contraindications to advance EN feeds (e.g., bowel obstruction/tight stenosis, severe diarrhea/malabsorption, gut ischemia, severe hypoxemia/acidosis, intractable upper gastrointestinal bleeding, abdominal compartment syndrome, high-output fistula).
1 Month
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sohag University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Abanob Amgad Francis
Pediatric Resident
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Safaa H Ali, MD, PhD
Role: STUDY_CHAIR
Sohag University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pediatric Intensive Care Unit - Sohag University Hospital
Sohag, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Martinez EE, Douglas K, Nurko S, Mehta NM. Gastric Dysmotility in Critically Ill Children: Pathophysiology, Diagnosis, and Management. Pediatr Crit Care Med. 2015 Nov;16(9):828-36. doi: 10.1097/PCC.0000000000000493.
Eveleens RD, Hulst JM, de Koning BAE, van Brakel J, Rizopoulos D, Garcia Guerra G, Vanhorebeek I, Van den Berghe G, Joosten KFM, Verbruggen SCAT. Achieving enteral nutrition during the acute phase in critically ill children: Associations with patient characteristics and clinical outcome. Clin Nutr. 2021 Apr;40(4):1911-1919. doi: 10.1016/j.clnu.2020.09.005. Epub 2020 Sep 16.
Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3):411-425. doi: 10.1007/s00134-019-05922-5. Epub 2020 Feb 20.
Mehta NM, Skillman HE, Irving SY, Coss-Bu JA, Vermilyea S, Farrington EA, McKeever L, Hall AM, Goday PS, Braunschweig C. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Pediatric Critically Ill Patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. Pediatr Crit Care Med. 2017 Jul;18(7):675-715. doi: 10.1097/PCC.0000000000001134.
Kratochvil M, Klucka J, Klabusayova E, Musilova T, Vafek V, Skrisovska T, Djakow J, Havrankova P, Osinova D, Stourac P. Nutrition in Pediatric Intensive Care: A Narrative Review. Children (Basel). 2022 Jul 11;9(7):1031. doi: 10.3390/children9071031.
Martinez EE, Pereira LM, Gura K, Stenquist N, Ariagno K, Nurko S, Mehta NM. Gastric Emptying in Critically Ill Children. JPEN J Parenter Enteral Nutr. 2017 Sep;41(7):1100-1109. doi: 10.1177/0148607116686330. Epub 2017 Jan 6.
Eveleens RD, Joosten KFM, de Koning BAE, Hulst JM, Verbruggen SCAT. Definitions, predictors and outcomes of feeding intolerance in critically ill children: A systematic review. Clin Nutr. 2020 Mar;39(3):685-693. doi: 10.1016/j.clnu.2019.03.026. Epub 2019 Mar 30.
Peng R, Li H, Yang L, Zeng L, Yi Q, Xu P, Pan X, Zhang L. The efficacy and safety of prokinetics in critically ill adults receiving gastric feeding tubes: A systematic review and meta-analysis. PLoS One. 2021 Jan 11;16(1):e0245317. doi: 10.1371/journal.pone.0245317. eCollection 2021.
Chiusolo F, Capriati T, Erba I, Bianchi R, Ciofi Degli Atti ML, Picardo S, Diamanti A. Management of Enteral Nutrition in the Pediatric Intensive Care Unit: Prokinetic Effects of Amoxicillin/Clavulanate in Real Life Conditions. Pediatr Gastroenterol Hepatol Nutr. 2020 Nov;23(6):521-530. doi: 10.5223/pghn.2020.23.6.521. Epub 2020 Nov 5.
Gomez R, Fernandez S, Aspirot A, Punati J, Skaggs B, Mousa H, Di Lorenzo C. Effect of amoxicillin/clavulanate on gastrointestinal motility in children. J Pediatr Gastroenterol Nutr. 2012 Jun;54(6):780-4. doi: 10.1097/MPG.0b013e31824204e4.
Caron F, Ducrotte P, Lerebours E, Colin R, Humbert G, Denis P. Effects of amoxicillin-clavulanate combination on the motility of the small intestine in human beings. Antimicrob Agents Chemother. 1991 Jun;35(6):1085-8. doi: 10.1128/AAC.35.6.1085.
Ciciora SL, Williams KC, Gariepy CE. Effects of Amoxicillin and Clavulanic Acid on the Spontaneous Mechanical Activity of Juvenile Rat Duodenum. J Pediatr Gastroenterol Nutr. 2015 Sep;61(3):340-5. doi: 10.1097/MPG.0000000000000804.
Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.
Straney L, Clements A, Parslow RC, Pearson G, Shann F, Alexander J, Slater A; ANZICS Paediatric Study Group and the Paediatric Intensive Care Audit Network. Paediatric index of mortality 3: an updated model for predicting mortality in pediatric intensive care*. Pediatr Crit Care Med. 2013 Sep;14(7):673-81. doi: 10.1097/PCC.0b013e31829760cf.
Abdelatif RG, Francis AA, Abdelkreem E, Ahmed SH. Amoxicillin for critically ill children with enteral nutrition intolerance (AmoxENI study): A randomized controlled trial. J Pediatr Gastroenterol Nutr. 2025 Sep;81(3):712-721. doi: 10.1002/jpn3.70105. Epub 2025 Jun 12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Soh-Med-23-04-16MS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.