Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-01 @ 10:10 PM
Study NCT ID:
NCT05828758
Status:
UNKNOWN
Last Update Posted:
2023-04-26
First Post:
2023-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amoxicillin for Enteral Nutrition Intolerance in Pediatric Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-22', 'releaseDate': '2024-10-05'}], 'estimatedResultsFirstSubmitDate': '2024-10-05'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Enrolled children will be equally randomized into study and control group using computer generated numbers, which will be sealed into sequentially numbered opaque envelopes by a person not belonging to the research team. For each enrolled participant, the envelope in order will be opened, and the assigned study drug will be used. A pharmacist will fill the active and placebo preparations in similar containers with sealed code for identification. Participants' families, treating clinicians, and investigators will be unaware of group assignment and drug/placebo therapy."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of children with enteral feeding intolerance:\n\nStudy 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.\n\nControl group: will receive equal volume of distilled water (0.2 ml/kg + 5 ml) as a placebo.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feeding tolerance on day 7', 'timeFrame': '7 days', 'description': 'Proportion of participants achieving feeding tolerance (enteral intake ≥ two-thirds of the prescribed daily target in the absence of gastrointestinal symptoms, including large gastric residual volume (≥ 50% of enteral feeding in the last 4 hours), vomiting (≥ 2 times gastric content in 24 hours period), diarrhea (≥ 4 times loose stool with negative fluid balance in 24 hours period), abdominal distention (≥ 2 cm increase in abdominal girth), abdominal pain, melena, or hematochezia) on day 7 study timepoint'}], 'secondaryOutcomes': [{'measure': 'Enteral intake ≥ two-thirds of the prescribed daily target on day 7', 'timeFrame': '7 days', 'description': 'Proportion of participants achieving enteral intake ≥ two-thirds of the prescribed daily target on day 7 study timepoint'}, {'measure': 'Change in achieved percentage of prescribed enteral feeding on day 7 study compared with baseline', 'timeFrame': '7 days', 'description': 'Change in achieved percentage of prescribed enteral feeding on day 7 study timepoint compared with baseline'}, {'measure': 'Large gastric residual volume on day 7', 'timeFrame': '7 days', 'description': 'Proportion of participants with large gastric residual volume (≥ 50% of enteral feeding in the last 4 hours) on day 7 study timepoint'}, {'measure': 'Vomiting on day 7', 'timeFrame': '7 days', 'description': 'Proportion of participants with vomiting (≥ 2 times gastric content in 24 hours period) on day 7 study timepoint'}, {'measure': 'Diarrhea', 'timeFrame': '7 days', 'description': 'Proportion of participants with diarrhea (≥ 4 times loose stool with negative fluid balance in 24 hours period)'}, {'measure': 'Abdominal distention', 'timeFrame': '7 days', 'description': 'Proportion of participants with abdominal distention (≥ 2 cm increase in abdominal girth)'}, {'measure': 'Melena/hematochezia', 'timeFrame': '7 days', 'description': 'Proportion of participants with melena/hematochezia'}, {'measure': 'Skin rash', 'timeFrame': '7 days', 'description': 'Proportion of participants with skin rash'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feeding intolerance', 'Pediatric intensive care unit', 'PICU', 'Amoxicillin'], 'conditions': ['Enteral Feeding Intolerance']}, 'referencesModule': {'references': [{'pmid': '26218259', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32981755', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32077997', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28691958', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35884015', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28061320', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30962102', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33428672', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33215023', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22584747', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1929247', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25844706', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19682776', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23863821', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40501446', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled study is to investigate the efficacy of enteral amoxicillin for the treatment of children with feeding intolerance in pediatric intensive care unit.\n\nChildren 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.\n\nThe primary outcome will be the improvement of feeding intolerance on day 7 study timepoint.', 'detailedDescription': 'Malnutrition is a common problem in critically ill children admitted to the pediatric intensive care unit (PICU) with a reported prevalence up to 57%. This condition is associated with increased length of hospital stay, morbidity (e.g., hospital-acquired infections, weakness, and longer duration of mechanical ventilation), and mortality. Data from observational studies indicate that adequate energy intake is associated with better outcomes in the PICU.\n\nEnteral 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.\n\nEN 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.\n\nAmoxicillin/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.\n\nThe goal of this randomized controlled study is to investigate the efficacy of enteral amoxicillin for the treatment of children with EN intolerance in PICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ranges from 1 month to 12 years.\n* Nasogastric tube feeding\n* Enteral nutrition intolerance after 7 days of admission to the PICU.\n\nExclusion Criteria:\n\n* Failure to obtain informed consent.\n* Allergy or contraindication to amoxicillin or other beta-lactam antibiotics.\n* Current or recent (within 7 days) treatment with amoxicillin.\n* Ongoing ketogenic diet.\n* 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).'}, 'identificationModule': {'nctId': 'NCT05828758', 'acronym': 'AmoxENI', 'briefTitle': 'Amoxicillin for Enteral Nutrition Intolerance in Pediatric Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Efficacy of Amoxicillin for Treatment of Enteral Nutrition Intolerance in Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': 'Soh-Med-23-04-16MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Children receiving amoxicillin', 'interventionNames': ['Drug: Amoxicillin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Comparison group', 'description': 'Children receiving placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Study group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Distilled water 0.2 ml/kg by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.', 'armGroupLabels': ['Comparison group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelrahim A Sadek, MD, PhD', 'role': 'CONTACT', 'email': 'abdoneurology@yahoo.com', 'phone': '+201065067057'}], 'facility': 'Pediatric Intensive Care Unit - Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Abanob Francis, MBBCh', 'role': 'CONTACT', 'email': 'abanobamgad@med.sohag.edu.eg', 'phone': '0201094930123'}, {'name': 'Elsayed Abdelkreem, MD, PhD', 'role': 'CONTACT', 'email': 'd.elsayedmohammed@med.sohag.edu.eg', 'phone': '+201114232126'}], 'overallOfficials': [{'name': 'Safaa H Ali, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After publication and for 3 years', 'ipdSharing': 'YES', 'description': 'Unidentified individual participant data will be available after publication from the principal investigator upon a reasonable request', 'accessCriteria': 'Through contacting the principal investigator by email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Resident', 'investigatorFullName': 'Abanob Amgad Francis', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-05', 'type': 'RELEASE'}, {'date': '2024-11-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Abanob Amgad Francis, Pediatric Resident, Sohag University'}}}}