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Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm (LACTEET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02133716
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
Laura Collados Gómez, Hospital General Universitario Gregorio Marañon

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Premature Infant Human Milk Breastfeeding Other: expressed breast milk Behavioral: sucrose 24% oral Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Breast Milk Expressed Versus Sucrose Relief Procedural Pain of Venipuncture in Preterm.
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arm Intervention/treatment
Experimental: 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.

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.


Active Comparator: 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.

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.





Primary Outcome Measures :
  1. Pain neonatal [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months ]

    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.



Secondary Outcome Measures :
  1. Percentage of crying [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months ]
    Relationship between duration procedure venipuncture and the time or duration of crying(from beginning to cry until terminated.)


Other Outcome Measures:
  1. Number of attempts [ Time Frame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months. ]
    Number of attempts during the venopuncture



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133716


Locations
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Spain
Hospital University Gregorio Marañon
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Publications:

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Responsible Party: Laura Collados Gómez, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT02133716    
Other Study ID Numbers: LACTEET
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: May 2014
Keywords provided by Laura Collados Gómez, Hospital General Universitario Gregorio Marañon:
pain
premature infant
sucrose
breastfeeding
expressed breast milk
PIPP
Additional relevant MeSH terms:
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Pain, Procedural
Pain
Neurologic Manifestations