Post-Discharge Growth and Development of Infants Who Received Targeted Fortification in the NICU

NCT04190875 | Suspended

• 1 other identifier: H-44733
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Infants

Keywords

Standard Protein Diet; High Protein Diet; Targeted Fortification; Post-Discharge Growth; Post-Discharge Body Compostion; Post-Discharge Neurodevelopment; Protein; Human Milk Diet; Prematurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Body composition measured by dual-energy x-ray absorptiometry (DXA)

  18-24 months corrected age

• Neurodevelopment will be measured by administration of The Bayley Scales of Infant and Toddler Development, 3rd Edition

  18-24 months corrected age

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children 18-24 months corrected age, who participated in an earlier study H-38611. These children were either born at Texas Children's Hospital in the first 24 hours of life and admitted to our Neonatal Intensive Care Unit. These infants had a birth weight of less than or equal to 1000 grams and were randomized to receive a standard protein diet (3.5-3.8 grams of protein per kilogram of body weight) or a high protein diet (4.2-4.5 grams of protein per kilogram of body weight). Infants in both groups received recommended clinical guidelines for protein.

You may qualify if:

• Children born prematurely, with birth weight of less than or equal to 1000 grams
• Born at Texas Children's Hospital or transferred to the Neonatal Intensive Care Unit from another hospital in the first 24 hours of life
• Completed a previous study (H-38611) in which the child received targeted protein fortification with donor human milk products

You may not qualify if:

• Infants not previously enrolled in a previous study (H-38611) in the Neonatal Intensive Care Unit at Texas Children's Hospital
• Infants enrolled in but did not complete a previous study (H-38611) in the Neonatal Intensive Care Unit at Texas Children's Hospital

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 26789484 BACKGROUND

• 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.

  PMID: 25130571 BACKGROUND

• 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.

  PMID: 24220185 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Amy B Hair, MD

  Baylor College of Medicine - Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: February 20, 2019
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)