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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04190875
Other study ID # H-44733
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date February 20, 2019
Est. completion date December 1, 2024

Study information

Verified date February 2024
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes. Postnatal growth standards are based on estimated intrauterine growth from historical cohort studies and post-mortem analyses. Despite current strategies aimed at appropriate nutrition, a large proportion of these infants have postnatal growth failure (anthropometric values < 10th percentile) reported in the literature as high as 89-99%. More recent data shows lower rates of postnatal growth failure but further improvement is still needed. Adequate growth is key to ensuring improved neurodevelopment and other outcomes. The investigators are currently evaluating the effects of a high versus standard protein enteral diet on growth and body composition in infants less than or equal to 1000 grams birth weight in the Neonatal Intensive Care Unit. (H-38611). Infants less than or equal to 1000 grams birth weight are provided an enteral diet with a level of protein based on individual caloric and protein analysis of human milk also known as targeted fortification. The standard protein diet provides 3.5-3.8 g/kg/day of protein, while the high protein diet provides 4.2-4.5 g/kg/day. The investigators have shown that infants who receive this diet achieve growth at targeted standards. As this diet is well tolerated and associated with improved outcomes in our highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Body composition in these infants receiving targeted fortification is being evaluated at 35-36 weeks post menstrual age. Because these infants are at such high risk for poor growth and neurodevelopment, it is important to investigate the impact of a higher protein exclusive human milk diet on long-term neurodevelopmental outcomes, body composition, and growth at 18-24 months.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Baylor College of Medicine / Texas Children's Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hair AB, Blanco CL, Moreira AG, Hawthorne KM, Lee ML, Rechtman DJ, Abrams SA. 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. J Pediatr. 2014 Nov;165(5):915-20. doi: 10.1016/j.jpeds.2014.07.005. Epub 2014 Aug 15. — View Citation

Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants </= 1250 grams birth weight. BMC Res Notes. 2013 Nov 13;6:459. doi: 10.1186/1756-0500-6-459. — View Citation

Hair AB, Peluso AM, Hawthorne KM, Perez J, Smith DP, Khan JY, O'Donnell A, Powers RJ, Lee ML, Abrams SA. Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet. Breastfeed Med. 2016 Mar;11(2):70-4. doi: 10.1089/bfm.2015.0134. Epub 2016 Jan 20. Erratum In: Breastfeed Med. 2017 Dec;12 (10 ):663. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Linear growth measured using a pediatric stadiometer Linear growth will be measured in centimeters (cm) at the time of the outpatient visit for DXA scan. 18-24 months corrected age
Secondary Body composition measured by dual-energy x-ray absorptiometry (DXA) The subject will be scanned once in infant mode and once in adult mode during the time of the outpatient visit. 18-24 months corrected age
Secondary Neurodevelopment will be measured by administration of The Bayley Scales of Infant and Toddler Development, 3rd Edition A developmental pediatrician will administer The Bayley Scales of Infant and Toddler Development at the time of the outpatient visit. This assessment consists of a series of developmental play tasks and takes between 45-60 minutes to administer and derives a developmental quotient. The measure consists of five scales. Raw scores of successfully completed items are converted to scale scores and to composite scores. Low/high scores for each scale are as following: Cognitive (55-145), Language (47-153), Motor (46-154), Social-Emotional (55-145). Children who score low on this assessment are at risk for future developmental problems. 18-24 months corrected age
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