This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

The overall objective is to evaluate the effectiveness of breastfeeding or supplemental breast milk in reducing procedural pain in neonates as assessed by physiologic [heart rate, respiratory rate, oxygen saturation and blood pressure] and/or behavioural (cry duration, proportion time crying, facial actions) pain indictors and/or validated composite pain scores.

Specific objectives are:

Primary
1. Compare breast feeding with control (placebo, no treatment, sucrose, glucose, pacifiers or positioning)
2. Compare breast milk with control (placebo, no treatment, sucrose, glucose, pacifiers or positioning)

Secondary
Within each comparison, to conduct subgroup analysis according to

1. Types of control intervention: placebo, no treatment, sucrose, glucose, pacifiers and positioning
2. Type of painful procedure: heel lance and venepuncture
3. Gestational age: preterm (<37 weeks) and full term (>37 weeks)
for procedural pain in neonates.

Within the group of supplemental breast milk, subgroup analysis based on the amount of breast milk will be carried out if data are available.