Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Study the Association of Early Nutritional Exposure With Cardiac Structure and Function in Preterm Infants During the First Year of Life: A Prospective Study
Preterm infants are babies born before 37 completed weeks of pregnancy. Early nutrition is important for their growth and development, and it may also be associated with how their heart develops and functions during infancy.
This prospective observational study aims to investigate the association between early nutritional exposure during the neonatal period and cardiac structure and function at 12 months of corrected age in preterm infants. The study will be conducted at Assiut University Hospital and El-Eman General Hospital in Assiut, Egypt.
Preterm infants born before 37 weeks of gestation who are admitted to the neonatal unit within 24 hours of birth, have adequate records of their nutritional intake, and whose parents provide written informed consent will be considered for participation. Infants with major congenital heart disease, known congenital cardiomyopathy, major genetic or chromosomal abnormalities, or other specified exclusion criteria will not be included.
The study will collect information about maternal and neonatal characteristics, neonatal complications, feeding patterns, growth, and anthropometric measurements. Cardiac structure and function will be assessed using echocardiography at birth, 6 months, and approximately 12 months of corrected age. Growth measurements will also be recorded at different time points, including 12 months of corrected age.
The study will compare cardiac measurements and growth outcomes among infants with different early nutritional exposures. It will also investigate which early nutritional and clinical factors are associated with left ventricular mass index at 12 months of corrected age.
The findings may improve understanding of the relationship between early nutrition and cardiovascular development in preterm infants. Participation will involve clinical data collection, growth measurements, and echocardiographic assessments, with written informed consent obtained from parents or legal guardians.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective observational study will investigate the association between early nutritional exposure during the neonatal period and cardiac structure and function during the first year of life in preterm infants.
**Study Setting and Population**
The study will be conducted at the Department of Pediatric Medicine, Assiut University Hospital and El-Eman General Hospital, Assiut, Egypt. The study population will include preterm infants born before 37 completed weeks of gestation who are admitted to the neonatal unit within 24 hours of birth, have adequate nutritional records, and whose parents provide written informed consent. Infants must be available for follow-up echocardiographic assessment at 12 months of corrected age.
**Eligibility Criteria**
Infants with major congenital heart disease, known congenital cardiomyopathy, major chromosomal or genetic abnormalities, congenital anomalies, or infections associated with or potentially affecting cardiac disease will be excluded. Infants with inadequate nutritional records, those whose parents refuse written consent, and those without follow-up at one year will also be excluded.
**Nutritional Exposure Groups**
The protocol describes the following feeding groups:
- Preterm infants receiving early complementary feeding at 17 weeks.
- Preterm infants receiving late complementary feeding after 26 weeks.
- Preterm infants receiving breastfeeding.
- Preterm infants receiving artificial feeding.
- Preterm infants receiving both breast milk and artificial feeding.
Nutritional exposure will be evaluated in relation to cardiac and growth outcomes. The final operational definitions and classification of feeding groups will follow the study protocol.
**Data Collection**
Maternal information will include maternal age, parity, mode of conception, obstetric history and complications, antenatal corticosteroid and magnesium sulfate administration, and mode of delivery.
Neonatal information will include sex, gestational age, singleton or multiple birth, birth weight, length, head circumference, small-for-gestational-age, appropriate-for-gestational-age or large-for-gestational-age classification, Apgar scores, and resuscitation requirements. Neonatal complications will include respiratory distress syndrome, surfactant use, duration of ventilation, and length of hospital stay.
Anthropometric measurements, including weight, length, and head circumference, will be recorded at birth, 36 weeks of postmenstrual age, hospital discharge, and 12 months of corrected age. Appropriate growth z-scores will be calculated using relevant reference standards.
**Echocardiographic Assessment**
Echocardiography will be performed at birth, 6 months, and approximately 12 months of corrected age (±2 weeks) by a single trained pediatric cardiologist blinded to the feeding group.
Cardiac structural measurements will include left ventricular end-diastolic and end-systolic dimensions, septal and posterior wall thickness, left ventricular mass index, relative wall thickness, left ventricular sphericity index, left atrial size, right ventricular basal dimension, and aortic root dimensions.
Cardiac functional measurements will include left ventricular ejection fraction and global longitudinal strain; mitral E/A ratio, septal and lateral e', E/e' ratio, and isovolumetric relaxation time; tricuspid annular plane systolic excursion, tricuspid S', right ventricular fractional area change, right ventricular free-wall strain, pulmonary acceleration time, and septal configuration. Patent foramen ovale and patent ductus arteriosus, if identified, will be documented as incidental findings.
**Study Outcomes and Statistical Analysis**
The primary objective is to investigate the association between early nutritional strategies and cardiac structure and function at 12 months of corrected age.
Secondary objectives include comparing left ventricular mass index z-scores, other echocardiographic parameters, and anthropometric outcomes among feeding groups, and developing a predictive model to identify early nutritional and clinical factors associated with left ventricular mass index at 12 months.
Data will be analyzed using the Statistical Package for the Social Sciences (SPSS). Continuous variables will be summarized as mean ± standard deviation or median and interquartile range, as appropriate. Categorical variables will be presented as frequencies and percentages. Comparisons will use one-way analysis of variance or the Kruskal-Wallis test, with appropriate post hoc correction, and the chi-square test or Fisher's exact test for categorical variables. Multivariable linear regression will be used for the predictive model. A p-value below 0.05 will be considered statistically significant.
Written informed consent will be obtained from parents or legal guardians, and participant information will be handled confidentially by the research team.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ahmed elhady assuit university
- Phone Number: 01002876470
- Email: ahmedalhady095@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Preterm infants at 1 year old age with past nutritional history avalible
Description
Inclusion Criteria:
- Preterm infants born at <37 weeks of gestation.
- preterm Infants admitted to the neonatal unit within 24 hours of birth.
- preterm Infants who have adequate records of nutritional intake during the neonatal period.
- Parents provided a consent for participation.
- preterm Infants available for follow-up echocardiographic assessment at 12 months corrected age.
Exclusion Criteria:
- preterm Infants with major congenital heart disease or known congenital cardiomyopathy.
- preterm Infants with major chromosomal, genetic abnormalities, congenital anomaly, or infections associated with or have potential for cardiac disease.
- Inadequate nutritional records.
- Refusal to provide written consent.
- Lack of follow-up at one year.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
- Group 1: Includes preterm Infants how receive early complementary feeding at 17 weeks.
Echocardiography is performed at Birth , 6 months and after 12 months corrected age |
Echocardiography is performed at Birth , 6 months and after 12 months corrected age (±2 weeks) by a single trained pediatric cardiologist blinded to the feeding group. The following parameters will be reported:
|
|
- Group 2: includes preterm infants how receive late complementary feeding After 26 weeks.
Echocardiography is performed at Birth , 6 months and after 12 months corrected age |
Echocardiography is performed at Birth , 6 months and after 12 months corrected age (±2 weeks) by a single trained pediatric cardiologist blinded to the feeding group. The following parameters will be reported:
|
|
- Group 3: includes preterm infants how receive breast feeding.
Echocardiography is performed at Birth , 6 months and after 12 months corrected age |
Echocardiography is performed at Birth , 6 months and after 12 months corrected age (±2 weeks) by a single trained pediatric cardiologist blinded to the feeding group. The following parameters will be reported:
|
|
-Group 4: includes preterm infants who receive artificial feeding.
Echocardiography is performed at Birth , 6 months and after 12 months corrected age |
Echocardiography is performed at Birth , 6 months and after 12 months corrected age (±2 weeks) by a single trained pediatric cardiologist blinded to the feeding group. The following parameters will be reported:
|
|
- Group 5: includes preterm infants who receive both breast and artificial feeding.
Echocardiography is performed at Birth , 6 months and after 12 months corrected age |
Echocardiography is performed at Birth , 6 months and after 12 months corrected age (±2 weeks) by a single trained pediatric cardiologist blinded to the feeding group. The following parameters will be reported:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
to investigate the association between early nutritional strategies and cardiac structure and function at 12 months of corrected age.
Time Frame: one year old age of preterm infants
|
one year old age of preterm infants
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
comparing left ventricular mass index z-scores, other echocardiographic parameters, and anthropometric outcomes among feeding groups
Time Frame: over one year period study
|
over one year period study
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Moyses HE, Johnson MJ, Leaf AA, Cornelius VR. Early parenteral nutrition and growth outcomes in preterm infants: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Apr;97(4):816-26. doi: 10.3945/ajcn.112.042028. Epub 2013 Feb 27.
- Kumar RK, Singhal A, Vaidya U, Banerjee S, Anwar F, Rao S. Optimizing Nutrition in Preterm Low Birth Weight Infants-Consensus Summary. Front Nutr. 2017 May 26;4:20. doi: 10.3389/fnut.2017.00020. eCollection 2017.
- Markopoulou P, Papanikolaou E, Analytis A, Zoumakis E, Siahanidou T. Preterm Birth as a Risk Factor for Metabolic Syndrome and Cardiovascular Disease in Adult Life: A Systematic Review and Meta-Analysis. J Pediatr. 2019 Jul;210:69-80.e5. doi: 10.1016/j.jpeds.2019.02.041. Epub 2019 Apr 13.
- Crump C, Groves A, Sundquist J, Sundquist K. Association of Preterm Birth With Long-term Risk of Heart Failure Into Adulthood. JAMA Pediatr. 2021 Jul 1;175(7):689-697. doi: 10.1001/jamapediatrics.2021.0131.
- Aye CYL, Lewandowski AJ, Lamata P, Upton R, Davis E, Ohuma EO, Kenworthy Y, Boardman H, Wopperer S, Packham A, Adwani S, McCormick K, Papageorghiou AT, Leeson P. Disproportionate cardiac hypertrophy during early postnatal development in infants born preterm. Pediatr Res. 2017 Jul;82(1):36-46. doi: 10.1038/pr.2017.96. Epub 2017 May 24.
- Schubert U, Muller M, Abdul-Khaliq H, Norman M. Preterm Birth Is Associated with Altered Myocardial Function in Infancy. J Am Soc Echocardiogr. 2016 Jul;29(7):670-8. doi: 10.1016/j.echo.2016.03.011. Epub 2016 May 4.
- Hamayun J, Mohlkert LA, Stoltz Sjostrom E, Domellof M, Norman M, Zamir I. Association between Neonatal Intakes and Hyperglycemia, and Left Heart and Aortic Dimensions at 6.5 Years of Age in Children Born Extremely Preterm. J Clin Med. 2021 Jun 9;10(12):2554. doi: 10.3390/jcm10122554.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Obstetric Labor, Premature
- Obstetric Labor Complications
- Pregnancy Complications
- Premature Birth
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Cardiac Imaging Techniques
- Ultrasonography
- Echocardiography
Other Study ID Numbers
- EarlyNutritionCardiac2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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