Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-28 @ 6:52 PM
Study NCT ID:
NCT07236957
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2025-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Nutritional Needs of Preterm Neonates Fed on Parenteral Nutrition and Effects on Body Weight Gain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D015430', 'term': 'Weight Gain'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The care providers who administered the parenteral (PN) solutions to the neonates were blinded to the identity of the PN solution.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 100 preterm and small for gestational age neonates were randomly assigned to either the Control group (n = 50) or the Intervention group (n = 50). Both groups received parenteral nutrition (PN) supported by a specialized clinical decision support system. In the Control group, the PN regimen was based on the actual birth weight, whereas in the Intervention group, calculations were based on the corrected weight corresponding to the 10th percentile of the growth curve.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight change', 'timeFrame': 'From birth day (day 1) till the last day of parenteral nutrition support (study endpoint). Each neonate had different PN duration according to their clinical status (average 12 days).', 'description': 'The primary outcome is to detect a statistical significant difference in body weight increase between the control and the intrevention group at the last day of parenteral nutrition support (study endpoint).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm neonates', 'parenteral nutrition', 'clinical decision support system', 'weight gain'], 'conditions': ['Preterm Infant Development', 'Preterm Infant Feeding Outcomes']}, 'referencesModule': {'references': [{'pmid': '23601190', 'type': 'BACKGROUND', 'citation': 'Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.'}]}, 'descriptionModule': {'briefSummary': "This randomized controlled trial included 100 preterm and small for gestational age neonates. The study aimed to determine the optimal approach for estimating nutritional needs in parenteral nutrition (PN) with the assistance of a specialized clinical decision support system (CDSS). More specifically, nutrient estimations based on the neonates' actual birth weight were compared to those calculated using the weight corresponding to the 10th percentile of the growth curve. The effect on growth outcomes over the PN course was investigated.", 'detailedDescription': 'Background: Parenteral nutrition (PN) plays a crucial role in providing nutritional support to premature and small for gestational age neonates.\n\nAim: In this randomized controlled study, we evaluated PN administration in preterm and small for gestational age neonates using the corrected weight estimated at the 10th percentile of the growth curve, as guided by a clinical decision support system (CDSS).\n\nMethods: A total of 100 preterm neonates were randomly assigned to either the Control group (n = 50) or the Intervention group (n = 50). Both groups received PN support using a specialized CDSS. In the Control group, the CDSS calculated the PN regimen based on the actual birth weight, whereas in the Intervention group, calculations were based on the corrected weight corresponding to the 10th percentile. Growth indicators (i.e., body weight, length, and head circumference) were measured at baseline and at the time of exclusive enteral feeding initiation. Blood samples were obtained at the last day of PN, after PN was ceased for 4 h and before oral feeding initiation. Electrolytes (sodium, potassium, calcium) and albumin concentrations, as well as red blood cells, white blood cells, haemoglobin and haematocrit were measured at the last day of PN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* preterm neonates hospitalized in NICU and meeting the criteria for small for gestational age infants, i.e., neonates with birth weight under the 10th percentile,\n* preterm neonates receiving exclusive parenteral nutrition, and\n* parents' written consent for study participation.\n\nExclusion Criteria:\n\n* term birth newborns or newborns not fullfilling the criteria of small for gestational age infants,\n* newborns with primary liver/bile duct disease,\n* newborns receiving enteral nutrition, and/or\n* neonates whose parents did not give a written consent to participate in the study"}, 'identificationModule': {'nctId': 'NCT07236957', 'briefTitle': 'Estimation of Nutritional Needs of Preterm Neonates Fed on Parenteral Nutrition and Effects on Body Weight Gain', 'organization': {'class': 'OTHER', 'fullName': 'Iaso Maternity Hospital, Athens, Greece'}, 'officialTitle': 'Corrected Weight to the 10th Percentile vs. Actual Birth Weight for the Calculation of Nutritional Needs of Small for Gestational Age Neonates Fed on Parenteral Nutrition: a Randomized-controlled Trial', 'orgStudyIdInfo': {'id': '21-11-18AB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Nutrient estimation based on the actual weight (Control group)', 'description': 'In the Control group, the clinical decision support system was used to determine parenteral nutriton requirements.', 'interventionNames': ['Dietary Supplement: Control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrient estimations based on the corrected weight (Intervention group)', 'description': 'In the Intervention group, the clinical decision support system was used to determine parenteral nutrition requirements.', 'interventionNames': ['Dietary Supplement: Intervention Group']}], 'interventions': [{'name': 'Intervention Group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In the Intervention group, the macronutrient composition in the parenteral nutrition solutions was calculated based on the corrected weight corresponding to the 10th percentile of the growth curve.', 'armGroupLabels': ['Nutrient estimations based on the corrected weight (Intervention group)']}, {'name': 'Control group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In the Control group, the parenteral nutrition regimen was estimiated based on the actual birth weight.', 'armGroupLabels': ['Nutrient estimation based on the actual weight (Control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15123', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Department of Nutrition, IASO Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to their containing information that could compromise the privacy of the research participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Panos Papandreou', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Peloponnese', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head Pharmacologist', 'investigatorFullName': 'Panos Papandreou', 'investigatorAffiliation': 'Iaso Maternity Hospital, Athens, Greece'}}}}