Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-08 @ 12:00 AM
Study NCT ID:
NCT00482560
Status:
COMPLETED
Last Update Posted:
2007-06-29
First Post:
2007-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007774', 'term': 'Lactation'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D049590', 'term': 'Postpartum Period'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-28', 'studyFirstSubmitDate': '2007-06-04', 'studyFirstSubmitQcDate': '2007-06-04', 'lastUpdatePostDateStruct': {'date': '2007-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Premature Infant Pain Profile (PIPP) scale rate (0-21)', 'timeFrame': '15 seconds before and Within 30 seconds after heel lance'}], 'secondaryOutcomes': [{'measure': 'Heart Rate Increase', 'timeFrame': 'within 30 seconds after heel lance'}, {'measure': 'Oxygen Saturation decrease', 'timeFrame': 'within 30 seconds after heel lance'}, {'measure': 'Duration of first cry', 'timeFrame': 'within 2 minutes after heel lance'}, {'measure': 'Percentage of crying time', 'timeFrame': 'within 2 minutes after heel lance'}, {'measure': 'Percentage of crying time', 'timeFrame': 'During blood sampling'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sucrose', 'Breastfeeding', 'Heel lance'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '15266438', 'type': 'BACKGROUND', 'citation': 'Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2004;(3):CD001069. doi: 10.1002/14651858.CD001069.pub2.'}, {'pmid': '12511452', 'type': 'BACKGROUND', 'citation': 'Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.'}, {'pmid': '16856069', 'type': 'BACKGROUND', 'citation': 'Shah PS, Aliwalas LI, Shah V. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004950. doi: 10.1002/14651858.CD004950.pub2.'}, {'pmid': '10617258', 'type': 'BACKGROUND', 'citation': 'Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the premature infant pain profile in the clinical setting. Clin J Pain. 1999 Dec;15(4):297-303. doi: 10.1097/00002508-199912000-00006.'}, {'pmid': '18762508', 'type': 'DERIVED', 'citation': 'Codipietro L, Ceccarelli M, Ponzone A. Breastfeeding or oral sucrose solution in term neonates receiving heel lance: a randomized, controlled trial. Pediatrics. 2008 Sep;122(3):e716-21. doi: 10.1542/peds.2008-0221.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose solution vs breastfeeding on neonatal screening heel lance', 'detailedDescription': 'Blood sampling heel lance for neonatal screening is the most frequent painful manoeuvre in Neonatal Units in healthy neonates.\n\nSome techniques showed efficacy evidence in reducing pain response: sucrose solutions, breastfeeding during blood sampling, topical local anaesthetics.\n\nA Cochrane Review in 2004 recommends the administration of sucrose 0.24-0.48 g (1-2 ml of 24% sucrose solution). It reduces PIPP scale rate about 20%.\n\nOur purpose is to compare the antinociceptive effect of 1 ml 30% sucrose solution administered 2 minutes before heel lancing vs blood sampling heel lance during breastfeeding.\n\nPIPP scale is a validated 7-indicator scale for the assessment of procedural pain in preterm and term neonates.\n\nInformant consent was asked parents during consultation by a Pediatrician of the Neonatal Unit of the Hospital in the last months of pregnancy.\n\nAfter parent written consent was obtained, 100 three day old neonates were randomized for treatment A (breastfeeding) or B (sucrose solution administration). The nurse opened consecutively numbered envelopes.\n\nTiming of operators: Group A Breastfeeding\n\n* The heel of neonate was warmed up by a glove full of water at 40° C for 2 minutes.\n* Monitoring of Oxygen Saturation and Heart Rate.\n* The neonate was breastfed by the mother till the nurse watched a continuous active suction.\n* Administration of first phase of PIPP scale (15 seconds before heel lance).\n* Digital Voice Record started\n* Heel Lance with an automated piercing device .\n* Squeezing for blood sampling till filling 4 catch basins for neonatal screening. If necessary a new heel lance was practiced.\n* Administration of the second phase of PIPP scale.\n* Record of duration of blood sampling and collateral effects\n* Stop Digital Voice Recording\n\nGroup B Sucrose administration\n\n* The neonate was laid on a baby-changing table.\n* The heel of neonate was warmed up by a gloves full of water a 40° C for 2 minutes.\n* Oral administration of 1 ml of 30% sucrose solution.\n* Monitoring of Oxygen Saturation and Heart Rate.\n* Administration of first phase of PIPP scale (15 seconds before heel lance).\n* Digital Voice Record starts\n* Heel Lance with an automated piercing device.\n* Squeezing for blood sampling till filling 4 catch basins for neonatal screening. If necessary a new heel lance was practiced.\n* Administration of the second phase of PIPP scale.Record of duration of blood sampling and collateral effects.\n* Stop Digital Voice Recording\n\nBlood sampling was practiced by skilled pediatric nurses. Registration of data, PIPP scale, voice record was made by a second operator, blind to the pur pose of the study.\n\nA third blind operator collected paper data and checked voice record (outcome cry behaviour).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term neonates, gestational age 37-42 weeks\n* Apgar \\>= 7\n* Not fed in the last 30 minutes\n* Informant consent\n\nExclusion Criteria:\n\n* Congenital malformation\n* Born in Caesarian Section in General Anaesthesia\n* Maternal use of opioids\n* Administration of Naloxone, Phenobarbital in the previous 48 hours\n* Impossibility of breastfeeding'}, 'identificationModule': {'nctId': 'NCT00482560', 'briefTitle': 'Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening', 'orgStudyIdInfo': {'id': 'PRN19341'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sucrose solution 30%1 ml', 'type': 'DRUG'}, {'name': 'Breastfeeding', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10064', 'city': 'Pinerolo', 'state': 'Torino', 'country': 'Italy', 'facility': 'Agnelli Hospital ASL 10', 'geoPoint': {'lat': 44.88534, 'lon': 7.33135}}], 'overallOfficials': [{'name': 'Luigi Codipietro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry'}, {'name': 'Alberto Ponzone, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Turin Department of Paediatric Science Doctorate in Experimental Pediatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agnelli Hospital, Italy', 'class': 'OTHER'}]}}}