Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm
NCT ID: NCT02133716
Last Updated: 2015-03-18
Study Results
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Basic Information
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COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2013-10-31
2014-10-31
Brief Summary
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This is an experimental comparative study of non-inferiority randomized crossover, to be performed in Neonatal units of hospitals in the Community of Madrid.
The 54 pair of preterm that after the selection criteria are included in the study, they performed the randomization of the sequence and breast milk expressed receive oral or 24% sucrose.
The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA), 0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior to venipuncture.
The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile (PIPP) and by percent of cry.
Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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expressed breast milk
A single dose of expressed breast milk was administered through a sterile syringe in the mouth 2 minutes before venopuncture to neonates, accompanied at all times provided the technique allows it to non-nutritive sucking and containment.
The doses administered: 0.1ml in infants less than 27 weeks , 0.25 ml for infants 27-31 weeks , 0.5 ml for infants 32-37 weeks.
expressed breast milk
The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
A single dose prior to venipuncture of expressed breast milk given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.
sucrose 24% oral
A single dose of sucrose was administered through a sterile syringe in the mouth 2 minutes before venopuncture to neonates, accompanied at all times provided the technique allows it to non-nutritive sucking and containment.
The doses administered: 0.1ml in infants less than 27 weeks , 0.25 ml for infants 27-31 weeks , 0.5 ml for infants 32-37 weeks.
sucrose 24% oral
The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
A single dose prior to venipuncture of oral sucrose 24% given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.
Interventions
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expressed breast milk
The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
A single dose prior to venipuncture of expressed breast milk given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.
sucrose 24% oral
The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
A single dose prior to venipuncture of oral sucrose 24% given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.
Eligibility Criteria
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Inclusion Criteria
* Weight less than 2500 grams.
* Feed breastfeeding (exclusive or not) or can obtain weight expressed breastmilk .
* Be informed and consent to the parents of those infants previously requested.
Exclusion Criteria
* infants with invasive artificial respiration
* infants with major congenital anomalies
* infants with grade II or IV intraventricular hemorrhage or strokes
* receiving parental sedatives or vasoactive drugs
* infants with necrotizing enterocolitis
* with surgical interventions
* infants in absolute diet
* infants with abstinence syndrome
25 Weeks
37 Weeks
ALL
No
Sponsors
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Hospital General Universitario Gregorio Marañon
OTHER
Responsible Party
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Laura Collados Gómez
Laura Collados Gómez
Locations
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Hospital University Gregorio Marañon
Madrid, Madrid, Spain
Countries
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References
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American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.
Bouza H. The impact of pain in the immature brain. J Matern Fetal Neonatal Med. 2009 Sep;22(9):722-32. doi: 10.3109/14767050902926962.
Bueno M, Stevens B, de Camargo PP, Toma E, Krebs VL, Kimura AF. Breast milk and glucose for pain relief in preterm infants: a noninferiority randomized controlled trial. Pediatrics. 2012 Apr;129(4):664-70. doi: 10.1542/peds.2011-2024. Epub 2012 Mar 5.
Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, Saizou C, Lapillonne A, Granier M, Durand P, Lenclen R, Coursol A, Hubert P, de Saint Blanquat L, Boelle PY, Annequin D, Cimerman P, Anand KJ, Breart G. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008 Jul 2;300(1):60-70. doi: 10.1001/jama.300.1.60.
Vinall J, Grunau RE. Impact of repeated procedural pain-related stress in infants born very preterm. Pediatr Res. 2014 May;75(5):584-7. doi: 10.1038/pr.2014.16. Epub 2014 Feb 5.
Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.
Lopez Maestro M, Melgar Bonis A, de la Cruz-Bertolo J, Perapoch Lopez J, Mosqueda Pena R, Pallas Alonso C. [Developmental centered care. Situation in Spanish neonatal units]. An Pediatr (Barc). 2014 Oct;81(4):232-40. doi: 10.1016/j.anpedi.2013.10.043. Epub 2013 Dec 2. Spanish.
Marin Gabriel MA, del Rey Hurtado de Mendoza B, Jimenez Figueroa L, Medina V, Iglesias Fernandez B, Vazquez Rodriguez M, Escudero Huedo V, Medina Malagon L. Analgesia with breastfeeding in addition to skin-to-skin contact during heel prick. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F499-503. doi: 10.1136/archdischild-2012-302921. Epub 2013 Jul 9.
Ors R, Ozek E, Baysoy G, Cebeci D, Bilgen H, Turkuner M, Basaran M. Comparison of sucrose and human milk on pain response in newborns. Eur J Pediatr. 1999 Jan;158(1):63-6. doi: 10.1007/s004310051011.
Ozdogan T, Akman I, Cebeci D, Bilgen H, Ozek E. Comparison of two doses of breast milk and sucrose during neonatal heel prick. Pediatr Int. 2010 Apr;52(2):175-9. doi: 10.1111/j.1442-200X.2009.02921.x. Epub 2009 Jul 16.
Ou-Yang MC, Chen IL, Chen CC, Chung MY, Chen FS, Huang HC. Expressed breast milk for procedural pain in preterm neonates: a randomized, double-blind, placebo-controlled trial. Acta Paediatr. 2013 Jan;102(1):15-21. doi: 10.1111/apa.12045. Epub 2012 Nov 1.
Shah PS, Herbozo C, Aliwalas LL, Shah VS. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004950. doi: 10.1002/14651858.CD004950.pub3.
Pillai Riddell RR, Racine NM, Turcotte K, Uman LS, Horton RE, Din Osmun L, Ahola Kohut S, Hillgrove Stuart J, Stevens B, Gerwitz-Stern A. Non-pharmacological management of infant and young child procedural pain. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD006275. doi: 10.1002/14651858.CD006275.pub2.
Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5.
Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.
Stevens B, Yamada J, Lee GY, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD001069. doi: 10.1002/14651858.CD001069.pub4.
Other Identifiers
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LACTEET
Identifier Type: -
Identifier Source: org_study_id
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