Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-29 @ 9:28 AM
Study NCT ID:
NCT00365703
Status:
COMPLETED
Last Update Posted:
2007-12-19
First Post:
2006-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007441', 'term': 'Intubation, Gastrointestinal'}], 'ancestors': [{'id': 'D007440', 'term': 'Intubation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-15', 'studyFirstSubmitDate': '2006-08-15', 'studyFirstSubmitQcDate': '2006-08-15', 'lastUpdatePostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean post conceptual age at which the infant is fed orally only.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infant, Premature', 'Tube feeding'], 'conditions': ['Infant, Premature']}, 'referencesModule': {'references': [{'pmid': '12856985', 'type': 'BACKGROUND', 'citation': 'Lau C, Smith EO, Schanler RJ. Coordination of suck-swallow and swallow respiration in preterm infants. Acta Paediatr. 2003 Jun;92(6):721-7.'}, {'pmid': '12520252', 'type': 'BACKGROUND', 'citation': 'Mizuno K, Ueda A. The maturation and coordination of sucking, swallowing, and respiration in preterm infants. J Pediatr. 2003 Jan;142(1):36-40. doi: 10.1067/mpd.2003.mpd0312.'}, {'pmid': '7892144', 'type': 'BACKGROUND', 'citation': 'Shiao SY, Youngblut JM, Anderson GC, DiFiore JM, Martin RJ. Nasogastric tube placement: effects on breathing and sucking in very-low-birth-weight infants. Nurs Res. 1995 Mar-Apr;44(2):82-8.'}, {'pmid': '7781566', 'type': 'BACKGROUND', 'citation': 'Haxhija EQ, Rosegger H, Prechtl HF. Vagal response to feeding tube insertion in preterm infants: has the key been found? Early Hum Dev. 1995 Mar 17;41(1):15-25. doi: 10.1016/0378-3782(94)01605-o.'}, {'pmid': '7428263', 'type': 'BACKGROUND', 'citation': 'Grunebaum M, Horodniceanu C, Wilunsky E, Reisner S. Iatrogenic transmural perforation of the oesophagus in the preterm infant. Clin Radiol. 1980 May;31(3):257-61. doi: 10.1016/s0009-9260(80)80211-x.'}, {'pmid': '8979310', 'type': 'BACKGROUND', 'citation': 'Arvedson JC, Lefton-Greif MA. Anatomy, physiology, and development of feeding. Semin Speech Lang. 1996 Nov;17(4):261-8. doi: 10.1055/s-2008-1064103.'}, {'pmid': '8780899', 'type': 'BACKGROUND', 'citation': 'Lau C, Schanler RJ. Oral motor function in the neonate. Clin Perinatol. 1996 Jun;23(2):161-78.'}, {'pmid': '1945550', 'type': 'BACKGROUND', 'citation': 'Stevenson RD, Allaire JH. The development of normal feeding and swallowing. Pediatr Clin North Am. 1991 Dec;38(6):1439-53. doi: 10.1016/s0031-3955(16)38229-3.'}, {'pmid': '11686975', 'type': 'BACKGROUND', 'citation': 'Pinelli J, Symington A. Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2001;(3):CD001071. doi: 10.1002/14651858.CD001071.'}, {'pmid': '12205253', 'type': 'BACKGROUND', 'citation': 'Simpson C, Schanler RJ, Lau C. Early introduction of oral feeding in preterm infants. Pediatrics. 2002 Sep;110(3):517-22. doi: 10.1542/peds.110.3.517.'}, {'pmid': '12183719', 'type': 'BACKGROUND', 'citation': 'Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.'}, {'pmid': '10755456', 'type': 'BACKGROUND', 'citation': 'Suess PE, Alpan G, Dulkerian SJ, Doussard-Roosevelt J, Porges SW, Gewolb IH. Respiratory sinus arrhythmia during feeding: a measure of vagal regulation of metabolism, ingestion, and digestion in preterm infants. Dev Med Child Neurol. 2000 Mar;42(3):169-73. doi: 10.1017/s001216220000030x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out which method (nasogastric vs. orogastric) of feeding tube for premature infants results in earlier only oral feeding.', 'detailedDescription': 'Preterm infants, even as young as 23 weeks gestational age, can be fed enterally at the first week of life. Coordination of sucking and swallowing, and coordination of both and breathing is necessary for efficient and safe oral feeding, and is not well established before the 35th week gestational age. That is why tube feeding is essential for preterm infants younger than that age.\n\nThere is no consensus regarding the best way for the feeding tube, i.e. oral vs. nasal, and whether placing the tube should be continuous or intermittently. Nasogastric tube has been associated with vagal responses. Both tubes may cause gastric perforation.\n\nDevelopment and function of oral feeding has been described. It is known that non-nutritive sucking and early introduction of oral feeding accelerate the transition from tube feeding to oral feeding. It is suggested that the preterm infant may experience a maturational lag in vagal function related to ingestive needs, which may contribute to continued feeding difficulties and may be a measurable marker of subtle neurodevelopmental problems. Both oral and nasal feeding tube may interfere with establishment of efficient oral feeding. The purpose of this study is to see whether there is a difference between oral and nasal tube feeding, regarding the institution of oral feeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All preterm infants, born during one year, who required tube feeding, and later discharged from neonatal intensive care unit.\n\nExclusion Criteria:\n\n* Infants who died during hospitalization\n* Infants with severe neurologic deficit (e.g. after Sarnat II-III asphyxia, or as a part of a syndrome\n* Infants with gastrostomy\n* Infants who were transferred to another hospital for any reason (e.g. heart surgery)'}, 'identificationModule': {'nctId': 'NCT00365703', 'briefTitle': 'Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best?', 'orgStudyIdInfo': {'id': '17/2006-1-HY-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Orogastric feeding tube.', 'interventionNames': ['Procedure: Feeding tube insertion']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Nasogastric feeding tube.', 'interventionNames': ['Procedure: Feeding tube insertion']}], 'interventions': [{'name': 'Feeding tube insertion', 'type': 'PROCEDURE', 'description': '1. Orogastric feeding tube\n2. Nasogastric feeding tube', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'state': 'Hadera', 'country': 'Israel', 'facility': 'Neonatal intensive care unit, Hille Yaffe medical center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Erez Nadir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe medical cenetr, Hadera, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Hillel Yaffe Medical Center', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}