1. Section Editor(s): Clifford, Patricia

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The Early Nutrition Study was a double-blind, parallel randomized clinical trial at 6 neonatal intensive care units in the Netherlands.1 The objective of the study was to determine whether providing donor milk instead of formula as a supplement when mother's milk was insufficient would reduce the incidences of necrotizing enterocolitis, serious infection, or all-cause mortality during the first 60 days of life. Enrolled infants weighed less than 1500 g. The participating centers admitted 930 very low birth-weight infants of which 377 were randomized of which 373 were entered. Infants receiving donor milk numbered 183 and 190 received formula. Mother's own milk was given 89% and 84.5% during the trial. The mean gestational age was 28.4 weeks and the mean birth weight was 1066 g. Some infants received exclusively mother's milk (7 in the donor group and 5 in the formula group), whereas 30 infants received either donor milks or formula exclusively (12 in the donor group and 18 in the formula group). The incident of combined outcome was not different, 44.7% formula and 42.1% donor milk. Neither negative nor beneficial effects for use of donor milk were found. This study does not provide information on why donor milk lacks short-term beneficial effects. Future trials should investigate longer duration of use of human donor milk on short- and long-term outcomes.


1. Corpelejin W, deWaard M, Christmann V, et al. Effect of donor milk on severe infections and mortality in very low birth weight infants. JAMA Pediatr. 2016;170:654-651. [Context Link]



Swaddling varies from culture to culture but has gained popularity in many countries including the United Kingdom and United States. Swaddling is usually defined as wrapping an infant in a light cloth leaving the head exposed. The benefits of swaddling are to promote more quite sleep time in infants less than 7 weeks of age. The purpose of this meta-analysis1 was to see whether there was any correlation for sudden infant death syndrome (SIDS) and swaddling for sleep.


A literature search from 1950 to 2014 was done and 4 studies were included in the review. Inclusion criteria included studies that were case control or cohort by design, used SIDS as an outcome as well as swaddling or infant wrapping.


In the 4 studies reviewed, the proportion of infants swaddled was higher in the SIDS cases than in the control cases. There were 760 SIDS cases compared with 1759 control subjects. The mean age of the swaddled infant was 57 days compared with 96 for nonswaddled. There was no significant difference of the age of the swaddled infants with SIDS. Swaddling peaked around 2 months in all studies and dropped off between 4 and 6 months. The risk of SIDS from swaddling increased with age and with infants greater than or equal to 6 months of life.


Positioning had noticeable effect on outcome. Infants swaddled and placed prone have the greatest risk of SIDS. In infants swaddled and placed prone or side position, the risk of SIDS doubles compared with nonswaddled infants. There was a small but significant risk of SIDS associated in the studies with being swaddled and placed on their backs.


Swaddling is more common with younger infants. Swaddling seems to be linked to SIDS in the older infant, which may be due to the ability of the infant to roll prone. Swaddling is encouraged in many countries to reduce excessive crying. Some countries like the Netherlands which have very low SIDS rates have issued guidelines not to initiate swaddling after 4 months and to stop swaddling as soon as the infant makes any attempt to turn over and all swaddling should be stopped by 6 months of life. Limitations to this meta-analysis is that the heterogeneity between studies was substantial and none of the studies adequately described the swaddling or wrapping technique used. Future studies are needed to address the issue of SIDS and swaddling and the appropriate age to stop swaddling.


1. Pease A, Fleming P, Hauck F, et al. Swaddling and the risk of sudden infant death syndrome: a meta-analysis. Pediatrics. 2016;137(6): e20153275. [Context Link]



Long-term alterations in cardiac morphology and function are associated with preterm births. This was a randomized control trial1 between 1982 and 1985 across 5 different United Kingdom centers involving 926 preterm infants weighing less than 1850 g and with no major congenital anomalies. The infants were randomized to either breast milk donated by an unrelated lactating woman or nutrient-enriched formula. A total of 102 infants from the original cohort were followed up of which 30 were fed human milk exclusively and 16 were formula. The comparison group consisted of 102 individuals born to uncomplicated full-term pregnancies. All participants were studied between the ages of 23 and 28 years. All received a cardiovascular magnetic resonance.


Initial study results showed that both groups, human milk and formula, had altered blood biochemistry profiles and elevated blood pressures when compared with the full-term control group. Premature infants in the human milk had an increase mean left ventricular end-diastolic volume index and left ventricular stroke volume index compared with the formula-fed group. Reduced thoracic cavity dimensions were noted in the formula-fed group as compared with the human milk group. There was no difference between the 2 groups with regard to the aortic diameter although the pulmonary artery diameter was larger in the formula-fed infants.


The evidence from this study shows an association that early nutrition in premature infants has an effect on cardiac structure and function in later life. Infants fed human milk had values that approached those infants who were full term.


Breast milk is noted to have greater bioactivity and bioavailability of growth factors, enzymes, and antibodies as compared with formula. The American Academy of Pediatric continues to recommend that preterm infants receive donor milk instead of preterm formula whenever possible. Breastfeeding is not able to reverse all cardiac changes related to the degree of prematurity, but the difference between those fed human milk versus formula is significant.


1. Lewandowski A, Lamata P, Francis J, et al. Breast milk consumption in preterm neonates and cardiac shape in adulthood. Pediatrics. 2016;138:e20160050. [Context Link]



The International Neonatal Consortium (INC) was launched to accelerate the development of safe and effective therapies for neonates.1 Neonates remain therapeutic orphans when it comes to drug development. The introduction of antenatal corticosteroids and surfactant were the last new medications introduced than have substantially improved outcomes for neonates. These drugs were introduced 20 to 25 years ago. In 2014, the first Annual Neonatal Workshop was cosponsored by Burroughs, Wellcome Fund, the Critical Path Institute and the FDA to help establish high-quality data to guide practice and regulatory discussion. The INC was launched in 2015 at the European Medicines Agency.


Nursing engagement and leadership in INC includes nursing education, family education, and nursing research. There needs to be a culture of embracing research in the NICUs to conduct trials that will evaluate safety and effectiveness of medicines and therapeutic interventions. Educating the nurses on the research process as well as educating the families on the value of research for improving outcomes is a main goal of INC. A culture that fosters research to enhance clinical trials is what is needed in NICUs. The NICU nurse can contribute to better patient outcomes by participating in bedside research and ultimately will be able to protect their patient from harm.




1. Short M. Neonatal nurses: key stakeholders in the International Neonatal Consortium. NeoReviews. 2016;17:e305. [Context Link]