Data sharing among data monitoring committees and responsibilities to patients and science.

Over the past three decades it has become increasingly recognized that systematic assessment of as high a proportion as possible of relevant research evidence is needed to protect the best interests of patients and the public. For example, this principle is manifested in clinical guidelines and, increasingly, in the design and monitoring of new research. For scientific and ethical reasons, those responsible for monitoring the progress of ongoing clinical trials may need to seek unpublished and interim data to protect the interests of actual or potential participants in research.

Oculomotor control in children who were born very prematurely.

Purpose: Preterm infants are at increased risk of a variety of cerebral lesions, involving the white matter, cortex, cerebellum, thalamus, and caudate nucleus, many of which could compromise the control of eye movement. Visual problems and disorders of binocularity and alignment have been reported, but little if any quantitative assessment of oculomotor control has been undertaken. The purpose of this study was to extend the initial pilot study and quantitatively examine the control of saccades, smooth pursuit, and antisaccades in children who were born very prematurely.

Conventional birth weight standards obscure fetal growth restriction in preterm infants.

Background And Objective: It has been suggested that fetal growth restriction (FGR) is associated with fetal maturation so that, compared with appropriately grown preterm infants, mortality and some neonatal morbidities may be reduced. The evidence for this is conflicting, and severe FGR has been shown to be harmful. In addition excessive growth has also been shown to be associated with poorer outcomes.

Good practice in consent.

Informed parental consent reminds the health professional to respect parent autonomy with respect to their infant's health care. It involves at least four elements: information, assessment of understanding, assessment of capacity, and freedom to choose. Critical issues are training of staff, timing of approach, and quality and presentation of information.

Reduction of oxidative stress marker in lung fluid of preterm infants after administration of intra-tracheal liposomal glutathione.

Background: Low levels of glutathione are associated with subsequent chronic lung disease in preterm infants. Incorporation of glutathione into liposomes offers a method of increasing levels with a prolonged half-life compared with direct inhalation.

Objectives: The aim of this study was to examine the clinical feasibility of administering a single dose of liposomal glutathione and its effectiveness at raising glutathione at 12 and 24 h after treatment.

Genetic polymorphisms and retinopathy of prematurity.

Purpose: Retinopathy of prematurity (ROP) is a major problem among very preterm survivors of neonatal intensive care. Neovascularization of the retina is prominent in the proliferative stages of ROP and is under the control of several factors such as vascular endothelial growth factor (VEGF). This study was undertaken on the hypothesis that genetic polymorphisms of VEGF, transforming growth factor (TGF)-beta1, and tumor necrosis factor (TNF)-alpha would occur more frequently in preterm infants with progressive ROP than in those with mild or no disease.

Caudate and hippocampal volumes, intelligence, and motor impairment in 7-year-old children who were born preterm.

Children who survive very preterm birth without major disability have a high prevalence of learning difficulty, attention deficit, and minor motor impairment (MMI). To determine whether these difficulties are associated with structural brain abnormalities, we studied 105 preterm children (<32 wk) at 7 y with tests of IQ and MMI (Movement ABC) and detailed magnetic resonance brain scans. Scans were assessed qualitatively for visible cerebral lesions.

Magnetic resonance imaging and T2 relaxometry of cerebral white matter and hippocampus in children born preterm.

The objective of this study was to determine whether intelligence and minor motor impairments in children who are born preterm without major disability are associated with cerebral white matter (CWM) and hippocampal abnormalities on magnetic resonance imaging (MRI). A total of 103 preterm children were studied at age 7 y with detailed magnetic resonance brain scans, including a T2-mapping sequence from which T2 relaxation times of the CWM and hippocampal formations were calculated. All of the children had no major motor disability, attended normal school, and had undergone assessment of IQ and a test for minor motor impairment (MMI).