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Completed

NCT Number: NCT02133716

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

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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Key information

Conditions

Pain Behavior Breast Feeding Breastfeeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Human Milk Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Premature Infant Signs and Symptoms Urogenital Diseases

Age range

25 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital University Gregorio Marañon

Madrid, 28007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Registry information

Official study title

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

Acronym: LACTEET

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 8, 2014
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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