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      A Pilot Single-Site Randomized Control Trial: Investigating the Use of Donor Milk in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit

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      research-article
      Author(s): , , , ,
      Publication date (Electronic):
      Journal: Research Square
      Publisher: American Journal Experts

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          Abstract

          Objective:

          We aimed to study the use of donor milk (DM) in term and late preterm infants (LPIs) when mother’s own milk (MOM) was unavailable. We hypothesized this study would be feasible and breastfeeding attempts and the percentage of MOM (MOM%) would increase with DM without adversely affecting growth.

          Study Design:

          This was a pilot study (n=32). Infants with gestational age >34 weeks admitted to the neonatal intensive care unit were included. Infants were randomized to: the human milk (MOM+DM) or formula (MOM+F) groups.

          Result:

          Consent rate was 52%. Breastfeeding attempts increased significantly over time in the MOM+DM group compared to the MOM+F group (group p=0.41, time p =0.02, group*time p=0.01). Growth at multiple time points was similar when the two groups were compared.

          Conclusion:

          A study randomizing term infants and LPIs to DM or formula when MOM is unavailable is feasible. DM may increase breastfeeding attempts without compromising growth.

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          Most cited references33

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          Donor Human Milk for the High-Risk Infant: Preparation, Safety, and Usage Options in the United States.

          (2017)
          The use of donor human milk is increasing for high-risk infants, primarily for infants born weighing <1500 g or those who have severe intestinal disorders. Pasteurized donor milk may be considered in situations in which the supply of maternal milk is insufficient. The use of pasteurized donor milk is safe when appropriate measures are used to screen donors and collect, store, and pasteurize the milk and then distribute it through established human milk banks. The use of nonpasteurized donor milk and other forms of direct, Internet-based, or informal human milk sharing does not involve this level of safety and is not recommended. It is important that health care providers counsel families considering milk sharing about the risks of bacterial or viral contamination of nonpasteurized human milk and about the possibilities of exposure to medications, drugs, or herbs in human milk. Currently, the use of pasteurized donor milk is limited by its availability and affordability. The development of public policy to improve and expand access to pasteurized donor milk, including policies that support improved governmental and private financial support for donor milk banks and the use of donor milk, is important.
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            Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants.

            Elizabeth Cristofalo, Richard J. Schanler, Cynthia L Blanco … (2013)
            To compare the duration of parenteral nutrition, growth, and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula (BOV) or donor human milk and human milk-based human milk fortifier (HUM), in a randomized trial of formula vs human milk. Multicenter randomized controlled trial. The authors studied extremely preterm infants whose mothers did not provide their milk. Infants were fed either BOV or an exclusive human milk diet of pasteurized donor human milk and HUM. The major outcome was duration of parenteral nutrition. Secondary outcomes were growth, respiratory support, and necrotizing enterocolitis (NEC). Birth weight (983 vs 996 g) and gestational age (27.5 vs 27.7 wk), in BOV and HUM, respectively, were similar. There was a significant difference in median parenteral nutrition days: 36 vs 27, in BOV vs HUM, respectively (P = .04). The incidence of NEC in BOV was 21% (5 cases) vs 3% in HUM (1 case), P = .08; surgical NEC was significantly higher in BOV (4 cases) than HUM (0 cases), P = .04. In extremely preterm infants given exclusive diets of preterm formula vs human milk, there was a significantly greater duration of parenteral nutrition and higher rate of surgical NEC in infants receiving preterm formula. This trial supports the use of an exclusive human milk diet to nourish extremely preterm infants in the neonatal intensive care unit. Copyright © 2013 Mosby, Inc. All rights reserved.
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              PediTools Electronic Growth Chart Calculators: Applications in Clinical Care, Research, and Quality Improvement

              Joseph Chou, Sergei Roumiantsev, Rachana Singh (2020)
              Background Parameterization of pediatric growth charts allows precise quantitation of growth metrics that would be difficult or impossible with traditional paper charts. However, limited availability of growth chart calculators for use by clinicians and clinical researchers currently restricts broader application. Objective The aim of this study was to assess the deployment of electronic calculators for growth charts using the lambda-mu-sigma (LMS) parameterization method, with examples of their utilization for patient care delivery, clinical research, and quality improvement projects. Methods The publicly accessible PediTools website of clinical calculators was developed to allow LMS-based calculations on anthropometric measurements of individual patients. Similar calculations were applied in a retrospective study of a population of patients from 7 Massachusetts neonatal intensive care units (NICUs) to compare interhospital growth outcomes (change in weight Z-score from birth to discharge [∆Z weight]) and their association with gestational age at birth. At 1 hospital, a bundle of quality improvement interventions targeting improved growth was implemented, and the outcomes were assessed prospectively via monitoring of ∆Z weight pre- and postintervention. Results The PediTools website was launched in January 2012, and as of June 2019, it received over 500,000 page views per month, with users from over 21 countries. A retrospective analysis of 7975 patients at 7 Massachusetts NICUs, born between 2006 and 2011, at 23 to 34 completed weeks gestation identified an overall ∆Z weight from birth to discharge of –0.81 (P<.001). However, the degree of ∆Z weight differed significantly by hospital, ranging from –0.56 to –1.05 (P<.001). Also identified was the association between inferior growth outcomes and lower gestational age at birth, as well as that the degree of association between ∆Z weight and gestation at birth also differed by hospital. At 1 hospital, implementing a bundle of interventions targeting growth resulted in a significant and sustained reduction in loss of weight Z-score from birth to discharge. Conclusions LMS-based anthropometric measurement calculation tools on a public website have been widely utilized. Application in a retrospective clinical study on a large dataset demonstrated inferior growth at lower gestational age and interhospital variation in growth outcomes. Change in weight Z-score has potential utility as an outcome measure for monitoring clinical quality improvement. We also announce the release of open-source computer code written in R to allow other clinicians and clinical researchers to easily perform similar analyses.
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                Author and article information

                Contributors
                Neema Pithia:
                ORCID: http://orcid.org/0000-0002-6314-6547
                Tristan Grogan
                Meena Garg
                Kalpashri Kesavan
                Kara Calkins:
                ORCID: http://orcid.org/0000-0001-6658-7981
                Journal
                Journal ID (nlm-ta): Res Sq
                Journal ID (publisher-id): ResearchSquare
                Title: Research Square
                Publisher: American Journal Experts
                Publication date (Electronic): 08 February 2023
                Electronic Location Identifier: rs.3.rs-2540272
                Affiliations
                UCLA, Los Angles, California
                UCLA, Los Angles, California
                UCLA, Los Angles, California
                University of California
                University of California
                Author notes

                AUTHOR CONTRIBUTIONS

                All authors contributed to the study and approved the final manuscript. Contributions included: Conceptualization, NP KLC, KK, MG; methodology, NP KLC, KK, MG; statistical analysis, NP TG; writing-original draft preparation, NP TG, KLC; writing-review and editing, NP TG, KK, MG, KLC; funding acquisition, NP TG, KLC.

                Author information
                http://orcid.org/0000-0002-6314-6547
                http://orcid.org/0000-0001-6658-7981
                Article
                Other ID: 10.21203/rs.3.rs-2540272
                DOI: 10.21203/rs.3.rs-2540272/v1
                PMC ID: 9934751
                PubMed ID: 36798190
                SO-VID: 2522660b-0967-41a8-8b80-5ef0c1f89e5a
                License:

                This work is licensed under a Creative Commons Attribution 4.0 International License, which allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use.

                License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License

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