Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm

Pain Clinical Trial

— LACTEET  

Official title:

Efficacy of Breast Milk Expressed Versus Sucrose Relief Procedural Pain of Venipuncture in Preterm.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133716
• Other study ID #: LACTEET
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2014
• Last updated: March 17, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2014
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

• Preterm neonates.

• 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:

• Maternal use of opioids or insulin-depent

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breastfeeding
• Human Milk
• Pain
• Premature Infant

Intervention

Other:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Hospital University Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & Publications (16)

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. Erratum in: Pediatrics. 2007 Feb;119(2):425. — View Citation

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. Review. — View Citation

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. — View Citation

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, Boëlle PY, Annequin D, Cimerman P, Anand KJ, Bréart 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. — View Citation

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. — View Citation

López Maestro M, Melgar Bonis A, de la Cruz-Bertolo J, Perapoch López J, Mosqueda Peña R, Pallás 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. — View Citation

Marín Gabriel MÁ, del Rey Hurtado de Mendoza B, Jiménez Figueroa L, Medina V, Iglesias Fernández B, Vázquez Rodríguez M, Escudero Huedo V, Medina Malagón 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. — View Citation

Ors R, Ozek E, Baysoy G, Cebeci D, Bilgen H, Türküner M, Basaran M. Comparison of sucrose and human milk on pain response in newborns. Eur J Pediatr. 1999 Jan;158(1):63-6. — View Citation

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;12:CD006275. — View Citation

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:CD004950. doi: 10.1002/14651858.CD004950.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Yes
Primary	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	Yes
Secondary	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	Yes