Neurophysiological Maturation Correlate With Clinical Milestones
Completed
Conditions studied: Neurophysiologic Maturation
In brief
To examine the association of early measures of heart rate variability and amplitude-integrated electroencephalography with time to wean to crib and to achieve full oral feeds among moderate and late preterm infants.
Key facts
- Study ID
- NCT03722901
- Run by
- Women and Infants Hospital of Rhode Island
- People needed
- 40
- Starts
- 2013-08-05
- Expected to finish
- 2017-05-02
- Last updated by the study team
- 2018-10-29
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Preterm cohort:
- Gestational age of either 32 weeks or 34 weeks by Obstetric criteria (presence of a sure LMP or sonogram performed in the first trimester, or agreement between LMP and a sonogram performed between the first trimester and 20 weeks)
- Admitted to a NICU of a participating institution
- Post-natal age less than 96 hours
- Term Cohort:
- Gestational age of 39-40 weeks
- Care provided in a Newborn Nursery or rooming in with the mother
You may not qualify if…
- Preterm Cohort:
- Major congenital anomaly/genetic anomaly
- Growth restriction (birth weight < 10%, Fenton growth curves)
- Unsure obstetric dating (e.g., absence of a sure LMP without a sonogram, earliest sonogram performed after 20 weeks without a sure LMP, or discrepancy between LMP and sonogram)
- Exposure to medications within the preceding 12 hrs which may affect CNS function (e.g., fentanyl, morphine, midazolam)
- Neonatal seizures
- Neonatal abstinence syndrome secondary to in-utero exposure to narcotics, methadone etc, or at high risk for development of abstinence
- Hypoxia-ischemia defined as the combination of fetal acidemia (cord gas or blood gas within 1 hour of birth: pH ≤ 7.15 or BE ≥ -10mEq/L), need for resuscitation at birth (PPV ± chest compressions or medications), and evidence of encephalopathy (Stage 1, 2 or 3 Sarnat). Stage 1 encephalopathy will be defined based on the level of consciousness which is characterized by a hyper-alert state, apparent alertness, and irritability. In the absence of a cord or early post-natal blood gas, there must be a history of a perinatal event which may have compromised oxygenation or blood flow to the fetus.
- Infants who are expected to be on mechanical (via an endotracheal tube) or high frequency ventilation for the first 96 hours after birth.
- Inability to obtain the informed consent
- Term Cohort:
- Any morbidity (eg, hypoglycemia [blood glucose < 40mg/dL] beyond 4 hours of age, abstinence, jaundice requiring phototherapy, sepsis evaluations which include obtaining blood cultures and initiation of antibiotics)
- Maternal complications of pregnancy (eg hypertension, diabetes mellitus, thyroid disorders, psychologic disorders requiring treatment with drugs such as SSRIs)
- Growth restriction (birth weight < 10%)
Where it is running
- Wayne State University — Detroit, Michigan, United States
- McGill University Health Center — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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