Active studies

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Eligible infants: 27 to 31 weeks of gestation or less and birthweight of 1500 grams or less

This is a multicenter, unmasked randomized clinical trial funded by NICHD (R01HD117932) in which very preterm infants fed human milk are randomly assigned to receive either 180 to 200 ml/kg/day or 140 to 160 ml/kg/day.

• Status: Recruiting

Eligible infants: 25 to 31 weeks of gestation 

This is an unmasked, multicenter randomized clinical trial funded by The Gerber Foundation in which  preterm infants fed human milk are randomly assigned to receive limited trophic feeding (20 to 25 mL/kg/day for one day) or extended trophic feeding (20 to 25 mL/kg/day for three days) 

• Status: Recruiting

Eligible infants: 32 weeks of gestation or less, birthweight below the 25th percentile

This is a masked randomized clinical trial in which very preterm infants fed human milk are randomly assigned to receive a DHA/ARA supplement during the first 3 weeks after birth.

• Status: Recruiting

Eligible infants: 32 weeks of gestation or less

This is a prospective cohort study of human milk diets during the early postnatal development of premature babies. We want to establish the correlation between skeletal muscle mass (SMM) measured by the D3-creatine (D3Cr) dilution method and FFM measured by air-displacement plethysmography. The D3Cr method involves a one-time oral dose of D3Cr.

• Status: Recruiting

Eligible infants: 28 - 32 weeks of gestation

This prospective cohort study aims to assess whether preterm neonates born between 28-32 weeks of gestation retain excess water during periods of stagnant weight loss by measuring total body water at four time points using non-invasive bioelectrical impedance analysis (BIA).

• Status: Recruiting

This study investigated the association between enteral protein intake and fat-free mass accretion in a cohort of 78 very preterm infants (<32 weeks gestation). We found that enteral protein intake (from milk or formula) was strongly linked to greater FFM accretion, that protein from intravenous nutrition showed less favorable associations with FFM gains, and that total protein intake (enteral + parenteral) was positively associated with weight gain. 

• Association Between Enteral Protein Intake and Fat-Free Mass Accretion in Very Preterm Infants - Neonatology

This observational study, which analyzed data from over 5,000 infants born between 24 and 26 weeks of gestation in US neonatal units, challenges the long-held practice of using weight-based growth metrics to predict cognitive outcomes. Our results show that a decline in head circumference and poor length growth are much stronger indicators of cognitive risk at two years of age.

• Risk Assessment of Cognitive Impairment at 2 Years of Age in Infants Born Extremely Preterm Using the INTERGROWTH-21st Growth Standards -  Journal of Pediatrics

In this secondary analysis of the TOP trial, we aimed to understand the mystery surrounding NEC development by examining the distribution of red-cell transfusions and the occurrence of NEC up to postnatal day 60. Hazard periods of exposure to red-cell transfusions were compared with control periods of non-exposure.

• Timing of Red Blood Cell Transfusions and Occurrence of Necrotizing Enterocolitis: A Secondary Analysis of a Randomized Clinical Trial - JAMA Network Open