Please select the eligibility criteria that correspond to the clinical trial below.
Title: Sucrose Practices for Pain in Neonates: A Program of Research: Part A (Trial 1 and 2): Determining the Minimally Effective Dose of Sucrose for Procedural Pain in Infants
Brief Summary: Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing pain during invasive procedures and is a standard of care for painful procedures. The purpose of this study is to see what is the least amount of sucrose that can be given to a baby to reduce pain during procedures.


Options:
A: Inclusion Criteria:

* must be born between 24 0/7 and 32 0/7 weeks of gestation
* must be hospitalized in the NICU
* it must be anticipated that they will need at least 5 routine heel sticks
* their parents give informed consent

Exclusion Criteria:

had a high-grade intraventricular hemorrhaging (grade III and IV);

* have a severe, life-threatening malformations;
* are suffering from any condition involving partial or total loss of sensitivity
* had a pHa \< 7.00;
* had surgery for any reason; or
* have a congenital malformation affecting brain circulation or the cardiovascular system.
B: Inclusion Criteria:

* Requiring retinal exam for ROP screening
* Clinically stable
* At least 30 0/7 weeks of corrected gestational age at the time of study
* Not on mechanical ventilation or CPAP at the time of study
* Requiring an inspired concentration of oxygen less than 50%

Exclusion Criteria:

* - Craniofacial malformations
* Cyanotic cardiac disease
* Hemodynamically significant cardiac lesions
* Known pneumothorax or pneumomediastinum
* Congenital pulmonary malformations
* Neuromuscular disease
* Receiving opiates, benzodiazepines or barbiturates at the time of study
C: 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).
D: 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.

Answer: C