Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
InfantNewborn8 moreThis pilot study was a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following a single intravenous dose of inositol. Based on previous studies, the premise is that maintaining inositol concentrations similar to those occurring naturally in utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants. The objective was to evaluate the single-dose pharmacokinetics and safety of different amounts of intravenous myo-inositol (provided by Ross Products Division, Abbott Laboratories) in very low birth weight neonates, in preparation for a future Phase III multi-center randomized controlled trial. This study enrolled 74 infants at high risk for retinopathy at 9 NICHD Neonatal Research Network sites, and randomly assigned them to receive either 60mg/kg of 5% inositol, 120 mg/kg of 5% inositol, 60 mg/kg of 5% glucose (the placebo), or 120 mg/kg of 5% glucose.
Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants
Neonatal HypotensionThe purpose of this study is to investigate the early use of hydrocortisone in hypotensive very low birth weight infants. Based on the observations that: hypotension is a common problem in very low birthweight infants and is associated with brain injury and poor neurological outcomes; some infants are refractory to standard treatment (volume expansion and vasopressors), which is not exempt of adverse effects; relative adrenal insufficiency has been described in this population; we hypothesize that hydrocortisone is effective in the treatment of hypotension in this population and reduce the need for vasopressors.
Effect of Tactile and Kinesthetic Stimulation on Very Low Birth Weight Preterm Infants
Preterm BirthTwo groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. One group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. Gain of weight, length and head circumference, date of the beginning of enteral feedings, length of time to recover birth weight and age of hospital discharge will be recorded and compared between both groups.
PregSource: Crowdsourcing to Understand Pregnancy
PregnancyPregnancy Complications5 morePregSource uses a crowd-sourcing approach, asking pregnant women to enter information regularly and directly about their pregnancies throughout gestation and the early infancy of their babies into online surveys and trackers via a website and/or mobile application ("app"). In exchange, participants can track their data over time, print out reports to share with their healthcare team, and see how they compare to other women. In addition, PregSource will provide participants with links to trusted, evidence-based information about pregnancy management, issues, and complications. More information is available at: https://pregsource.nih.gov
Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
AnemiaThe purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.
Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor...
InfantVery Low Birth Weight4 moreThis study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children). PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN). SECONDARY ENDPOINT: To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants; To compare growth and nutritional status of the 2 groups by randomized arm. To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery will be executed. To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding). DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months. INCLUSION CRITERIA Weight at birth ranging: 700 - 1501 grams; Gestational age up to 25 weeks and 6 days; Written informed consent from parents or guardians EXCLUSION CRITERIA Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract) Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC) Pre-existing cutaneous disease not allowing the placement of the probe
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to...
Apnea of PrematurityThe purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).
Summary of Infants Weighing 500 Grams or Less
InfantExtremely Low Birth Weight1 moreThis is a retrospective single-center cohort study. The comparison in short- and long-term outcomes will be made between those with and without primary microcephaly in infants weighing ≤ 500 g.
Delayed Cord Clamping in VLBW Infants
InfantNewborn6 moreThis study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
InfantNewborn7 moreThis study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.