Efficacy of Breast Milk Expressed Versus Sucrose Relief Procedural Pain of Venipuncture in Preterm.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Pain neonatal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Weeks to 37 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Percentage of crying(Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months)
Investigators
Laura Collados Gómez
Laura Collados Gómez
Hospital General Universitario Gregorio Marañon