VLBW: Non-Protein Energy (2020)

Author and Year:
Hair A, Blanco C, et al 2014
PubMed ID:
Article Title:
Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight.
Authors:
Hair A, Blanco C, Moreira A, Hawthorne K, Lee M, Rechtman D, Abrams S
Journal:
The Journal of Pediatrics
Year of publication:
2014
Volume:
165
Issue:
5
Page numbers:
915-20
Study Design:
Randomized Controlled Trial
Risk of Bias Assessment Rating:
Positive
Inclusion Criteria:
750-1250 g BW; reasonable expectation of survival for study duration through 36 weeks postmenstrual age (PMA) or weaned from fortification (whichever comes first) ; adherence to a feeding protocol providing an exclusive HM-based diet and potentially a donor HM-derived cream supplement; achievement of enteral feeds by 21 days of life; informed consent from parent or legal guardian
Exclusion Criteria:
Infants were excluded that had: major congenital anomalies or clinically significant congenital heart disease; low expectation for survival; high potential for early transfer to a nonstudy institution; enrollment in another clinical study that affected nutritional management; failure to start minimum enteral feeds before 21 days of life; presence of intestinal perforation or stage 2 NEC by modified Bell Criteria7 prior to tolerating fortified feeds; inability to participate in the study for any reason based on the decision of the study investigator.
Research Purpose:
To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control).
Blinding efforts:
After informed written parental consent was obtained, infants were randomized into 1 of 2 groups via blocks of 4, the size of which was blinded (cream or control group). Because of the nature of the interventions by which the nutrition was prepared and delivered, masking of the study groups was not possible at 1 site. The cream supplement mixes readily with HM and its addition does not change the composition or consistency of the HM. At 1 site, we were unable to prepare the milk and deliver it to the infant in a blinded fashion for logistical reasons.
Study Location:
Texas Children''s Hospital, Houston, TX and University Health System, San Antonio, TX
Source(s) of Funding:
Government, Industry
Please specify names of funders:
US Department of Agriculture/Agricultural Research Service (58-6250-6-001) National Center for Research Resources General Clinical Research for Children (RR00188) Prolacta Bioscience provided the product for the study and assisted in data analysis A.H. and C.B. received financial support and receive speaker honoraria from Prolacta Bioscience M.L. and D.R. are employees of Prolacta Bioscience
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
5. Was blinding used to prevent introduction of bias? Yes
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? Yes
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) Yes
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? No
  8.6. Was clinical significance as well as statistical significance reported? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? No