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The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| expressed breast milk | Experimental | 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. |
|
| sucrose 24% oral | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| expressed breast milk | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain neonatal | The pain neonatal will be determined by the scale Premature Infant Pain Profile (PIPP). The PIPP scale is a multidimensional measure developed to assess pain in preterm and term infants. It consists of three behavioral indicators (facial actions: philtrum, frowning, clenched eyes), two physiological indicators (heart rate and oxygen saturation) and two measures of development (gestational age and behavioral state). Each pointer may take four values on a scale from 0 to 3, which is subsequently added to an overall score. The score range from 0 (no pain or the presence of minimal pain) to 21 (maximum pain) in preterm. PIPP score was evaluated at 30 seconds after venopuncture Both the validity and reliability of this scale have been studied and proven in various studies. The PIPP scale will it be monitored by skilled and experienced nurses in neonatal care. | Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of crying | Relationship between duration procedure venipuncture and the time or duration of crying(from beginning to cry until terminated.) | Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attempts | Number of attempts during the venopuncture | Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital University Gregorio Marañon | Madrid | Madrid | 28007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17079598 | Background | 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. | |
| 19526425 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D047928 | Premature Birth |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| sucrose 24% oral | Behavioral | 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. |
|
| 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. |
| 22392169 | Background | 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. |
| 18594041 | Background | 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. |
| 24500615 | Background | 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. |
| 12205254 | Background | 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. |
| 24290892 | Background | 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. |
| 23839984 | Background | 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. |
| 9950311 | Background | 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. |
| 19627552 | Background | 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. |
| 23057434 | Background | 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. |
| 23235618 | Background | 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. |
| 21975752 | Background | 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. |
| 22392168 | Background | 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. |
| 8722730 | Background | 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. |
| 23440783 | Background | 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. |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D000073893 |
| Sugars |