Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT04062851
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Unblinded Single center Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-22', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days to reach full enteral feeds', 'timeFrame': '1 month after enrollment', 'description': 'Days to reach enteral feeding volume of 120ml/kg/day'}], 'secondaryOutcomes': [{'measure': 'Necrotizing enterocolitis', 'timeFrame': 'Until hospital discharge, an average of 2-6 months', 'description': 'Stage 2 NEC and higher grade'}, {'measure': 'weight gain', 'timeFrame': '4 weeks chronological age and 36 weeks corrected gestation', 'description': 'Weight gain velocity in gm/kg/d'}, {'measure': 'frequency of feeding interruptions', 'timeFrame': 'Until full feeds are reached, usually between 2 weeks - 2 months', 'description': 'Number of timed feeds are withheld'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric residuals, feeding, very low birth weight infants'], 'conditions': ['Gastric Residual Volume', 'Preterm Infant', 'Feeding Disorder Neonatal']}, 'referencesModule': {'references': [{'pmid': '25129325', 'type': 'RESULT', 'citation': 'Li YF, Lin HC, Torrazza RM, Parker L, Talaga E, Neu J. Gastric residual evaluation in preterm neonates: a useful monitoring technique or a hindrance? Pediatr Neonatol. 2014 Oct;55(5):335-40. doi: 10.1016/j.pedneo.2014.02.008. Epub 2014 Aug 14.'}, {'pmid': '25166623', 'type': 'RESULT', 'citation': 'Torrazza RM, Parker LA, Li Y, Talaga E, Shuster J, Neu J. The value of routine evaluation of gastric residuals in very low birth weight infants. J Perinatol. 2015 Jan;35(1):57-60. doi: 10.1038/jp.2014.147. Epub 2014 Aug 28.'}, {'pmid': '25633400', 'type': 'RESULT', 'citation': 'Parker L, Torrazza RM, Li Y, Talaga E, Shuster J, Neu J. Aspiration and evaluation of gastric residuals in the neonatal intensive care unit: state of the science. J Perinat Neonatal Nurs. 2015 Jan-Mar;29(1):51-9; quiz E2. doi: 10.1097/JPN.0000000000000080.'}]}, 'descriptionModule': {'briefSummary': 'The practice of checking gastric residuals is not evidence based. The amount of gastric residual volume (GRV) does not correlate with either feeding intolerance or development of NEC. We hypothesize that not monitoring GRV in infants with birth weights \\< 1,250 g, and who are being fed intermittently by gastric tube, will result in earlier attainment of full feeding. This is an unblinded randomized controlled trial where GRV will not be checked routinely in the intervention group.', 'detailedDescription': 'The term "gastric residuals" in neonates refers to aspiration of gastric contents before each feeding in an infant receiving enteral feeding using an intermittent feeding tube. The presence of significant gastric residual volume (GRV) (Greater than 50% of the feeding volume) is a manifestation of delayed gastrointestinal maturation in a preterm neonate. The presence of GRV and its characteristics usually delays advancement of enteral feedings in premature infants because a large volume of undigested milk usually prompts the clinicians to hold the feeding.\n\nAdvancement of early enteral nutrition is delayed or discontinued for \\>24 hours in nearly 75% of all extremely preterm infants. This is despite clinical evidence showing that early establishment of enteral nutrition is associated with reductions in the severity of critical illness, and long-lasting benefits on linear growth and neurodevelopmental outcomes.\n\nThe magnitude and characteristics of GRV combined with specific findings based on abdominal examinations are usually considered by clinicians in decisions to continue with the scheduled enteral feeding plan. There are no studies to establish the normal volume of gastric residuals, its characteristics and whether routinely checking for them prior to each feed prevents necrotizing enterocolitis. A recent cohort study using retrospective controls showed that not monitoring GRV is associated with earlier attainment of full feeding in very low birth weight infants. Two small randomized studies conducted outside the United States and one study conducted in the United States showed no difference in outcomes when GRV are not checked routinely in preterm infants. These studies have several drawbacks and the practice of checking GRV continues.\n\nStudy Objectives\n\nPrimary Objective/Aim/Goal/Hypothesis\n\nThe primary objective of this study is to demonstrate that not monitoring GRV in infants with birth weights \\< 1,250 g, and who are being fed intermittently by gastric tube, will result in earlier attainment of full feeding.\n\nHypothesis:\n\nIn preterm infants, changing the clinical practice from routine gastric residuals evaluation to no aspiration for gastric residuals will decrease the number of days to reach full enteral feeds.\n\nSecondary Objective/Aim/Goal/Hypothesis\n\nA secondary objective is to show that there will be no difference in the incidence of NEC (necrotizing enterocolitis) in the experimental vs the control group.\n\nSample Size Determination\n\nOur NICU database shows that for infants \\<1,250 g the days to full feeding was 16.4 ±7.3 days. To detect a relative decrease of 20% in the experimental group will require 73 infants in each group with an alpha of 0.05 and a power of 0.8.\n\nStatistical Analysis Plan\n\nPrimary Objective Analysis\n\nThe primary outcome analysis is the number of days to reach full feeding volume, defined as volume \\> 120 ml/kg/d. This time will be compared between the two groups using analysis of variance.\n\nSecondary Objective Analysis\n\nSecondary analysis will be focused the frequency of feeding interruptions, incidences of NEC between the two groups using analysis of variance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '2 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Birth weight ≤1250g\n2. Gestational age of \\< 33 weeks\n3. Expected to receive feeds via gastric tubes\n\nExclusion Criteria:\n\n1. Death expected within 72 hours of birth\n2. Major chromosomal or congenital anomaly\n3. Major GI anomaly such as gastroschisis, spontaneous perforation etc.'}, 'identificationModule': {'nctId': 'NCT04062851', 'briefTitle': 'Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Routine Versus no Assessment of Gastric Residual Volumes in Very Low Birth Weight Infants Receiving Enteral Feeding Via Intermittent Feeding Tubes: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '1255832'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'GRV group', 'description': 'Gastric residuals will be checked prior to feeds'}, {'type': 'EXPERIMENTAL', 'label': 'NO GRV group', 'description': 'Gastric residuals will not be checked prior to feeds', 'interventionNames': ['Other: No Gastric residual volume monitoring']}], 'interventions': [{'name': 'No Gastric residual volume monitoring', 'type': 'OTHER', 'description': 'Gastric residual volumes will not be monitored', 'armGroupLabels': ['NO GRV group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Narendra Dereddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}