Human milk or preterm formula after hospital discharge in infants born at 32-34 weeks: effects on growth, nutritional status, and feeding tolerance

ISRCTN	ISRCTN23549837
DOI	https://doi.org/10.1186/ISRCTN23549837
Medical and Health Project of the Science	PKJ2023-Y59
Technology Development Fund of Pudong New Area for Public Welfare Research	PKJ2024-Y09
Sponsor	Shanghai First Maternity and Infant Hospital
Funders	Technology Development Fund of Pudong New Area for Public Welfare Research, Medical and Health Project of the Science

Submission date: 10/11/2026
Registration date: 13/11/2026
Last edited: 13/11/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jing Li
Public, Scientific, Principal investigator

2699 Gaoke West Road, Pudong New Area
Shanghai
201204
China

Phone	+86 18918302861
Email	lijing_yfy@tongji.edu.cn

Study information

Primary study design	Observational
Observational study design	Cohort study
Scientific title	Post-discharge human milk or preterm formula in infants born at 32⁺⁰-34⁺⁶ weeks: growth, micronutrient status and feeding tolerance in routine care
Study objectives	1. To compare weight gain velocity from hospital discharge to 4 months postmenstrual age between the two groups (primary outcome) 2. To compare length gain velocity, head circumference gain velocity, z-scores for weight/length/head circumference, and the proportion of catch-up growth (Δz ≥ 0.67), hemoglobin, serum ferritin, 25-hydroxyvitamin D levels, the detection rates of anemia, iron deficiency and vitamin D insufficiency, as well as feeding tolerance (secondary outcomes) 3. To describe the actual utilization rate of human milk fortifier 4. To provide local evidence for the development of individualized post-discharge feeding and follow-up management pathways for moderate-late preterm infants
Ethics approval(s)	Approved 11/12/2022, Medical Ethics Committee of Shanghai First Maternity and Infant Hospital (2699 Gaoke West Road, Pudong New Area, Shanghai, 201204, China; +86 021-20261000; kjk@51mch.com), ref: 53
Health condition(s) or problem(s) studied	Post-discharge human milk or preterm formula in healthy late moderate preterm infants
Methodology	Post-discharge nutrition of late and moderately preterm infants is poorly evidenced, and feeding mode may shape catch-up growth and micronutrient status. This study compares growth, micronutrient status and feeding tolerance in infants born at 32⁺⁰–34⁺⁶ weeks' gestation (moderate-to-late preterm; M/LPT) fed human milk or post-discharge preterm formula to 4 months' corrected gestational age (CGA), and documents fortifier use in routine care. In this single-centre, non-randomised, open-label cohort, healthy M/LPT infants were enrolled and analysed: human milk (≥ 75% of intake) or post-discharge preterm formula , to 4 months' CGA. The primary outcome was weight growth velocity; length and head-circumference velocity, haemoglobin (Hb), serum ferritin, 25-hydroxyvitamin D (25OHD) and tolerance were secondary; velocities were adjusted for gestational age and birth weight (ANCOVA; sex as sensitivity analysis).
Intervention type	Other
Primary outcome measure(s)	Weight gain velocity, calculated by serial weight records measured using standard WHO calibrated weighing scales at discharge and 4 months of corrected gestational age
Key secondary outcome measure(s)	Length and head circumference growth velocity, calculated by serial length and head circumference records measured using standard WHO measuring tape at discharge and 4 months of corrected gestational age Weight/length/head circumference-for-age z-scores and catch-up growth proportion (Δz ≥ 0.67), measured using the WHO Child Growth Standards at 4 months of corrected gestational age Levels of hemoglobin, serum ferritin, 25-hydroxyvitamin D measured using clinical laboratory biochemical tests at 4 months of corrected gestational age Feeding tolerance from discharge to 4 months of corrected gestational age, measured using clinical feeding records (including vomiting, abdominal distension, feeding interruption), accessed at the end of the study
Completion date	30/04/2025

Eligibility

Participant type(s)
Age group	Neonate
Lower age limit	7 Days
Upper age limit	2 Weeks
Sex	All
Target sample size at registration	68
Total final enrolment	64
Key inclusion criteria	1. "Healthy" late moderate preterm infants with a gestational age of 32+0 to 34+6 weeks (determined by last menstrual period or first-trimester ultrasound) at a postmenstrual age of 2 weeks (about 2 weeks after birth) 2. Clinically stable 3. Can tolerate full enteral feeding
Key exclusion criteria	1. Congenital malformations (including but not limited to gastrointestinal malformations, congenital heart disease, chromosomal abnormalities, etc.) 2. Diseases affecting growth, including severe bronchopulmonary dysplasia (requiring inspired oxygen concentration >30% or continuous positive airway pressure beyond a postmenstrual age of 36 weeks), metabolic disorders (e.g., congenital hypothyroidism, phenylketonuria, etc.), severe cardiac or renal diseases, necrotizing enterocolitis with extensive bowel resection, grade IV intraventricular hemorrhage 4. Use of medications that may affect food digestion, absorption or sleep (e.g., sedatives, glucocorticoids, etc.) 5. Infants whose parents refuse participation or are unable to complete follow-up
Date of first enrolment	01/01/2023
Date of final enrolment	31/12/2024

Locations

Countries of recruitment

China

Study participating centre

Shanghai First Maternity and Infant Hospital

2699 Gaoke West Road, Pudong New Area, Shanghai , China
Shanghai
201204
China

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

12/11/2026: Study’s existence confirmed by the Medical Ethics Committee of Shanghai First Maternity and Infant Hospital, China.