Please select the eligibility criteria that correspond to the clinical trial below.
Title: Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
Brief Summary: Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.

The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.


Options:
A: Inclusion Criteria:

* Informed consent from parent or legal guardian.
* Term, newborn infant, between 1 and 7 days of age.
* Appropriate for gestational age (weight 5th through 95th percentile).

Exclusion Criteria:

* Small or large for gestational age (weight\<5th or \>95th percentile).
* Physical or biochemical abnormalities.
* History of maternal drug dependence.
* Apgar score \<7 at 5 minutes.
* Current use of analgesics.
B: Inclusion Criteria:

* born at a gestational age between 32+0 and 36+6 weeks,
* being nourished with breast milk
* the necessity for a clinical blood sample.

Exclusion Criteria:

* perinatal asphyxia,
* birth trauma,
* condition of cardio-respiratory instability,
* condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
* drug abuse of the mother
* and application of sedative medication to mother or child.
C: Inclusion Criteria:

* Healthy, full term, normally breastfeeding infants, whose mother is willing to breastfeed during the painful procedure and consents to study participation. Normally breastfeeding infants will be defined as those infants who had fed directly at the breast a minimum of two times in the 24-hours prior to blood collection and whose mother and/or staff nurse reported active sucking and swallowing during those feeds. Infants who have undergone repeated heel lancing for blood glucose and/or bilirubin monitoring (e.g., small or large for gestational age infants, infants born to diabetic mothers, or with hyperbilirubinemia) will be considered eligible, however, diagnosis and the number of prior painful procedures will be recorded and retained for statistical analysis.

Exclusion Criteria:

* Infants will not be eligible for study participation if they are a twin birth (including all classifications of monozygotic and dizygotic twins) due to the potential for non-independence of outcomes between twin pairs, show signs of infection, significant lower limb tissue damage, have had previous surgery or intra-ventricular hemorrhage, are born to opioid using mothers or with significant genetic disorders, are unable to breastfeed or have contraindications to sucrose administration, or whose parents are unable to provide written informed consent.
D: Inclusion Criteria:

* Infants 24 to 42 weeks gestational age (GA) at birth, admitted to the Neonatal Intensive Care Unit (NICU), and scheduled to receive a heel lance will be eligible. Parents will be approached for participation within the first 2 weeks of the infant's life. Infants will be eligible for Trial 1, the non-opioid trial, if they have not received any opioids within 24 hours prior to the heel lance. Infants will be eligible for Trial 2, the opioid trial, if they are currently receiving an opioid infusion. Furthermore, observation of the procedures will be timed to ensure that no additional sucrose doses are provided within the previous 4 hours.

Exclusion Criteria:

* Infants will be excluded if they have a contraindication for sucrose administration (e.g., unable to swallow, pharmacologically muscle relaxed, or heavily sedated) due to safety concerns and/or inability to assess pain accurately (e.g., unable to clearly view the infant's face).

Answer: B