Pre-term Infant Clinical Trial
Official title:
Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants: a Multi-centered, Open-label Clinical Trial
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | October 2025 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 10 Days |
| Eligibility | Inclusion Criteria: 1. Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation. 2. Infants' birth weight =1500 g and AGA. 3. Infant's gestational age < 37 weeks. 4. Infant is clinically stable and does not have deteriorating respiratory function after birth. 5. Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (=240 hours) of life. Exclusion Criteria: 1. Parent(s) not willing / not able to comply with the requirements of study protocol. 2. Infant is experiencing early onset sepsis. 3. Major congenital or chromosomal abnormality known to affect growth. 4. Liver failure. 5. Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification). 6. Infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk. 7. Infant's participation in another interventional clinical trial. 8. Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day). |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Klinika Neonatologii, Szpital Uniwersyteck | Bydgoszcz | |
| Poland | Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy | Kraków | |
| Serbia | Clinical Center of Serbia | Belgrad | |
| Slovakia | Univerzitna nemocnica Martin | Martin | |
| Slovakia | Fakultna nemocnica s poliklinikou Nove Zamky | Nove Zamky |
| Lead Sponsor | Collaborator |
|---|---|
| Société des Produits Nestlé (SPN) |
Poland, Serbia, Slovakia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Growth | Weight-adjusted weight gain (g/kg/day) | From FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier | |
| Secondary | Weight at other time points | Changes in weight gain (g/day and g/kg/day) | From Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months | |
| Secondary | Other growth parameter (length) | Change in length (cm/week) | From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months | |
| Secondary | Other growth parameter (head circumference) | Change in head circumference (cm/week) | From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months | |
| Secondary | Anthropometric z-scores for weight, length and head circumference | Corresponding z-scores and changes in z-scores expressed using Fenton growth chart will be analyzed | From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months | |
| Secondary | Feeding intake at neonatal unit | Neonatal unit feeding questionnaire capturing timing, type, rate and amount of feeding (parenteral & enteral), gastric residual volumes, number of missed feedings | Baseline + weekly over 3 consecutive days starting on pre-FEF Day1 + weekly over 3 consecutive days starting on FEF Day1 until Neonatal Unit Discharge (on average 7 weeks after birth) | |
| Secondary | Stool frequency at neonatal unit | Stool frequency (range from 0-20 times a day) collected via neonatal unit questionnaire | Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth) | |
| Secondary | Stool consistency at neonatal unit | Stool consistency (watery, mushy soft, runny, formed, hard) collected via neonatal unit questionnaire | Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth) | |
| Secondary | Bloody stools at neonatal unit | Bloody stools (yes or no) collected via neonatal unit questionnaire | Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth) | |
| Secondary | GI symptoms at neonatal unit | GI symptoms (incidence of abdominal distention, regurgitation, spitting and vomiting) collected via neonatal unit questionnaire | Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth) | |
| Secondary | Feeding intake after discharge | Parent-reported 3-Day Intake Diary capturing the total number of bottles of formula and approximate volumes consumed per day | 3 consecutive days just prior to the 30-day PD and 60-day PD visits | |
| Secondary | Stool frequency after discharge | Stool frequency captured via parent-reported 3-Day Intake Diary | 3 consecutive days just prior to the 30-day PD and 60-day PD visits | |
| Secondary | Stool consistency after discharge | Stool frequency captured via parent-reported 3-Day Intake Diary | 3 consecutive days just prior to the 30-day PD and 60-day PD visits | |
| Secondary | GI symptoms after discharge | GI symptoms (such as presence of stomach ballooning, bloody stools, regurgitation, spitting-up and vomiting) captured via parent-reported 3-Day Intake Diary | 3 consecutive days just prior to the 30-day PD and 60-day PD visits | |
| Secondary | GI-related behaviors after discharge | GI-related behaviors (such as crying and sleep quality) captured via parent-reported 3-Day Intake Diary | 3 consecutive days just prior to the 30-day PD and 60-day PD visits | |
| Secondary | Serum biomarkers for protein status | Serum albumin and blood urea nitrogen (BUN) | At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD | |
| Secondary | Serum biomarkers for bone health | Serum P, alkaline phosphatase, calcium and creatinine | At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD | |
| Secondary | Urine biomarkers for bone health | Urinary Ca, P and creatinine | At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD | |
| Secondary | Vitamin D | Vitamin D | FEF Day 1, Neonatal Unit Discharge and at 60 days PD | |
| Secondary | Fecal microbiota | Fecal microbiota composition, diversity and metabolism markers (SCFAs) | Baseline, FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, at 30 day-PD and 60 days PD | |
| Secondary | Fecal markers for gut health / maturation and immune status | Fecal levels of calprotectin, alpha 1 antitrypsin, pancreatic elastase (i.e. chymotrypsin-like elastase family, member 3B (CELA3B)), Human beta-defensin 2 (HBD2) and secretory IgA | Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD | |
| Secondary | Urine markers for gut health / maturation and immune status | Urinary level (spot urine sample) of intestinal fatty acid binding protein (iFABP) | Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD | |
| Secondary | AE reporting | Number of AEs through investigator-confirmed AE reporting | From the time the mother has consented to the infant's participation in the study until the 60 days PD visit | |
| Secondary | Bayley-III scores | Bayley scales of Infants and Toddler development - 3rd edition | At 12, 18, and 24 months | |
| Secondary | Developmental Milestone scores | Parent-reported achievements of specific-age appropriate milestones (yes/no reponses to child performing specific milestones or not) | At 12, 18, and 24 months | |
| Secondary | Child temperament scores | Parent-reported child temperament questionnaire | At 12, 18, and 24 months | |
| Secondary | Number of healthcare usage | Retrospective paret-reported recall of the number of healthcare usage and hospitalizations | At 12, 18, and 24 months | |
| Secondary | Feeding patterns | Feeding practice outcomes collected retrospectively at each visit via a parent-reported questionnaire related to breastfeeding duration, prevalence of formula feeding, and age at initiation of complementary feeding | At 12, 18, and 24 months |