Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Control Trial Evaluating the Effect of Two Different Doses of Amino Acids on Growth and Serum Amino Acids in Premature Neonates Admitted to the NICU
Brief Summary: Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Despite an increase in growth during the second month of hospitalization, many neonates are ultimately discharged home having grown inadequately. The early nutritional deficit affects weight gain as well as growth in length and head circumference.

Growth measurements such as weight, length, and head circumference, however, are macroscopic measures of nutritional status and underestimate the physiologic consequences of prolonged nutritional deprivation. Energy and micronutrient deficiencies alter growth at a cellular and tissue level before macroscopic measures are altered. In the brain, for instance, energy is required for cell division and neuronal growth, glial cell function, and myelination. Energy deprivation may consequently alter neuronal function and growth, resulting in adverse neurodevelopmental outcomes.

Immunocompetence also appears to be sensitive to the untoward effects of energy and nutritional deficiency. Malnourished neonates often exhibit immune deficiencies related to inadequate protein intake that compound an already immature immune system. Such immunodeficiency results in susceptibility to infectious agents that creates substantial morbidity and mortality to the course of intensive care for premature infants.

A recent study suggests that postnatal malnutrition and growth restriction are inevitable if current recommended dietary intakes are followed. Multicenter studies show that variation in dietary intake accounts for 45% of the variation in growth. Hence, efforts have focused on determining whether nutritional deficiency and the observed growth restriction of premature infants can be prevented through the use of more optimal nutritional intake. In addition, inadequate protein support may be a primary cause for growth failure.

Based on animal studies showing high in utero amino acid flux observed during the latter phase of gestation, Thureen et al have suggested the use of higher doses of amino acid supplementation in order to minimize growth restriction and improve outcomes of premature infants. However there are no large human trials that demonstrate that this approach promotes better growth or that it is safe. While small doses of amino acids may be inadequate to promote normal growth, high doses may lead to elevated serum amino acid levels and increase the occurrence of toxicity. Through the implementation of a multicenter, randomized trial and tandem mass spectrometry, the investigators propose to evaluate the effects of two distinct strategies of amino acid supplementation on serum amino acid profiles and growth of premature infants during the first 28 days of life.


Options:
A: Inclusion Criteria:

* Documentation of informed consent
* Inborn
* Gestational age between 23 weeks and 0/7 days and 29 weeks and 6/7 days
* If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
* No major anomalies
* Ability to begin parenteral nutrition within the first 48 hours after birth

Exclusion Criteria:

* Outborn
* Gestational age \< 23 weeks or \>= 30 weeks
* Any major congenital anomalies
B: Inclusion Criteria:

* Cardiovascular failure and/or respiratory failure:

  1. Cardiovascular Failure: Dopamine or dobutamine \> 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, phenylephrine, milrinone or vasopressin if used to treat hypotension.
  2. Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy.
* Age \>= 2 weeks and corrected gestational age \>= 42 weeks
* Age \< 18 years (has not yet had 18th birthday)

Exclusion Criteria:

* No longer has cardiovascular or respiratory failure (as defined in inclusion criterion 1), or is expected to be extubated in the next 24 hours
* Expected to remain in ICU \< 24 hours
* Previously randomized in HALF-PINT
* Enrolled in a competing clinical trial
* Family/team decision to limit/redirect from aggressive ICU technological support
* Chronic ventilator dependence prior to ICU admission (non-invasive ventilation and ventilation via tracheostomy overnight or during sleep are acceptable)
* Type 1 or 2 diabetes
* Cardiac surgery within prior 2 months or during/planned for this hospitalization (extra-corporeal life support or non-cardiac surgery is acceptable)
* Diffuse skin disease that does not allow securement of a subcutaneous sensor
* Therapeutic plan to remain intubated for \>28 days
* Receiving therapeutic cooling with targeted body temperatures \<34 degrees Celsius
* Current or planned ketogenic diet
* Ward of the state
* Pregnancy
C: Inclusion Criteria:

* Children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours

Exclusion Criteria:

* Expected stay \< 24 hours
* Therapy restriction upon admission
* No informed consent
* Other study enrollment
D: Inclusion Criteria:

* All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission

Exclusion Criteria:

* Age of 17 years or older
* Patients with a DNR code at the time of ICU admission.
* Patients expected to die within 12 hours (=moribund patients).
* Patient readmitted to ICU after randomization to the PEPaNIC trial, more than 48 hours after the initial discharge
* Patients transferred from another paediatric intensive care after a stay of more than 7 days
* Patients suffering from ketoacidotic or hyperosmolar coma on admission.
* Patients suffering from Short Bowel Syndrome on home PN or other conditions that require home PN
* Patients suspicious or established inborn metabolic diseases requiring specific diet
* STRONGkids score lower than 2 on ICU admission.
* Premature Newborns ( 37 weeks gestational age upon admission in the PICU)
* Prior inclusion in another randomized controlled outcome study

Answer: A