Clinical trial NCT02133716: Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm
Official title: Efficacy of Breast Milk Expressed Versus Sucrose Relief Procedural Pain of Venipuncture in Preterm.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Premature Infant
Human Milk
Breastfeeding
Keywords: pain
premature infant
sucrose
breastfeeding
expressed breast milk
PIPP
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 54
Sex: ALL
Minimum age (years): 25
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain neonatal
timeFrame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months
Secondary outcomes:
measure: Percentage of crying
timeFrame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months
Other outcomes:
measure: Number of attempts
timeFrame: Midpoint analysis will be conducted when half the patients are recruited, at an estimated time of 12 months.
Locations:
city: Madrid
country: Spain
facility: Hospital University Gregorio Marañon
Study officials:
References:
citation: 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.
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