Randomized Controlled Trial of Two Timepoints for Introduction of Standardized Complementary Food in Preterm Infants

Abstract

In term infants it is recommended to introduce solids between the 17th and 26th week of life, whereas data for preterm infants are missing. In a prospective, two-arm interventional study we investigated longitudinal growth of VLBW infants after early (10–12th) or late (16–18th) week of life, corrected for term, introduction of standardized complementary food. Primary endpoint was height at one year of age, corrected for term, and secondary endpoints were other anthropometric parameters such as weight, head circumference, BMI, and z-scores. Among 177 infants who underwent randomization, the primary outcome could be assessed in 83 (93%) assigned to the early and 83 (94%) to the late group. Mean birthweight was 941 (SD ± 253) g in the early and 932 (SD ± 256) g in the late group, mean gestational age at birth was 27 + 1/7 weeks in both groups. Height was 74.7 (mean; SD ± 2.7) cm in the early and 74.4 cm (mean; SD ± 2.8; n.s.) cm in the late group at one year of age, corrected for term. There were no differences in anthropometric parameters between the study groups except for a transient effect on weight z-score at 6 months. In preterm infants, starting solids should rather be related to neurological ability than to considerations of nutritional intake and growth.

Preterm Infants on Early Solid Foods and Iron Status in the First Year of Life—A Secondary Outcome Analysis of a Randomized Controlled Trial

“…Other hematologic parameters important for iron status were comparable between groups. This indicates that early introduction of solid foods in the vulnerable patient group of extremely low birth weight infants is safe concerning their iron status [13].…”

“…The study was conducted from October 2013 to February 2020 at a level IV neonatal care unit of the Department of Pediatrics, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics (Medical University of Vienna, Vienna, Austria). The study design and the primary outcome were recently published [13]. Inclusion criteria were a gestational age <32 weeks of gestation and a birth weight <1500 g. Infants with diseases affecting stable growth, i.e., necrotizing enterocolitis (NEC) with short bowel syndrome [14], Hirschsprung disease [15], chronic inflammatory bowel disease [16], bronchopulmonary dysplasia (BPD) [17], congenital heart disease [18], or major congenital birth defects or chromosomal aberrations were not eligible.…”

“…Infants were fed age-appropriate standardized complementary food in addition to breastfeeding or formula until one year corrected for prematurity. Details on the standardized feeding boxes were previously described [13]. Infants with a weight <10th percentile at discharge received fortified breast milk (Aptamil FMS, Milupa Nutricia GmbH, Frankfurt, Germany) or preterm discharge formula until 52 weeks corrected age.…”

“…Participants were invited to study visits at expected due date, 6 weeks, 12 weeks, 6 months, and 12 months corrected age along with clinical routine care visits at the neonatal outpatient clinic. Anthropometric measurements were collected at every visit, and results were published previously [13]. Blood samples were taken at 6 weeks corrected age before solid foods were started, as well as at 6 and 12 months corrected age, respectively.…”

“…Detailed demographic parameters as well as information on neonatal morbidity and nutritional parameters were published previously [13], and parameters related to the iron status of infants are shown in Table 1. There were no significant differences between study groups.…”