Thursday, 30 October 2025

FEED 1 JC

 A

Here are the 20 questions again with as many actual answers from the FEED1 trial (published in The Lancet Child & Adolescent Health) as available from publicly-reported sources:

General Understanding

  1. What was the main objective of the FEED1 Trial?
    Answer: To determine whether, in infants born at 30+0 to 32+6 weeks gestation, giving full milk feeds initiated in the first 24 h after birth (i.e., exclusively enteral fluids from day 1) reduces the length of infant hospital stay compared with gradual milk feeds plus intravenous fluids. (BioMed Central)

  2. Which population of infants was included in the trial?
    Answer: Infants born between 30+0 and 32+6 weeks gestation (inclusive) and eligible to be randomised within about 3 hours of birth. (BioMed Central)

  3. What type of study design was used?
    Answer: A multi-centre, open-label, parallel-group, randomised controlled superiority trial. (The Lancet)

  4. How many participants were enrolled?
    Answer: 2,088 infants were recruited from 46 UK neonatal units over ~4.75 years. (The Lancet)

  5. What were the inclusion and exclusion criteria for infants?
    Answer:

    • Inclusion: Infants born at 30+0 to 32+6 weeks gestation; eligible for randomisation within ~3 h of birth. (BioMed Central)

    • Exclusion: Infants with known congenital gastrointestinal anomalies making enteral feeding unsafe; small-for-gestational-age (<10th centile) with reversed end-diastolic flow on umbilical artery Doppler; mothers who had participated in previous pregnancy in trial. (BioMed Central)

Intervention and Comparison

  1. What was the intervention tested?
    Answer: The intervention arm received “full milk feeds” starting from day 1 (60 mL/kg/day of milk), with all fluid requirement enteral from birth (no intravenous fluids) wherever feasible. (BioMed Central)

  2. What was the control or comparison group given?
    Answer: The control group received gradual milk feeding according to usual local practice, which typically included slower increments of enteral feeds along with intravenous fluids or parenteral nutrition. (BioMed Central)

  3. How was “early feeding” defined in the trial protocol?
    Answer: Early feeding in this context meant initiating full milk feeds in the first 24 h after birth (day 1) with exclusively enteral fluids. (BioMed Central)

  4. What type of feeds (breast milk, formula, donor milk) were used in the intervention?
    Answer: The trial preferred mother’s expressed breast milk. If insufficient, supplementation with donor breast milk or formula milk was allowed (especially in the early days) as per local policy. (BioMed Central)

  5. How was feeding tolerance measured in the study?
    Answer: The protocol specified daily feeding logs until the infant receives at least 140 mL/kg/day of feeds sustained for 3 consecutive days. (BioMed Central)

Outcomes and Results

  1. What was the primary outcome measure of the trial?
    Answer: The primary outcome was length of infant hospital stay (time until discharge) among eligible infants. (BioMed Central)

  2. What were the secondary outcomes evaluated?
    Answer: Secondary outcomes included time until objective discharge criteria met (e.g., weight ≥1700 g, full suck feed, off temperature support ≥24 h), rates of necrotising enterocolitis (NEC), late-onset sepsis, hypoglycaemia, growth metrics, and six-week follow up, among others. (BioMed Central)

  3. Did early enteral feeding increase the risk of necrotising enterocolitis (NEC)?
    Answer: No increase in the risk of NEC was reported in the full-milk (day 1 feeding) arm compared with the gradual group. (EurekAlert!)

  4. What were the findings regarding time to reach full feeds?
    Answer: While the protocol expected the early group might reach full enteral feeds sooner, publicly available press-releases state that babies fully milk-fed from day 1 required fewer medical interventions and less intensive-care time, though I could not locate the exact numeric difference in time to full feeds in the public summary. (EurekAlert!)

  5. How did early feeding affect hospital stay or growth outcomes?
    Answer: According to press releases: Babies in the full milk arm had a hospital stay similar to the control group (around 30–35 days) but appeared to require fewer medical interventions and less intensive-care time, without compromising safety. (University of Nottingham)

Statistical and Ethical Aspects

  1. What statistical methods were used to analyze the data?
    Answer: The statistical plan (from the protocol) indicated use of linear mixed models to compare mean length of hospital stay between groups, adjusting for minimisation variables and accounting for correlation within multiple births. Analyses will follow intention-to-treat, with sensitivity analyses for deaths prior to discharge. (BioMed Central)

  2. Was the study adequately powered to detect significant differences?
    Answer: Yes — the sample size was calculated as 2,088 infants to detect a difference of 2 days in mean length of stay with 90% power, assuming a standard deviation of 13 days and accounting for clustering from multiple births. (BioMed Central)

  3. Were there any ethical concerns raised during the trial?
    Answer: The protocol described use of a two-stage consent pathway (antenatal consent when possible; otherwise oral assent postnatally then full written consent later) because infants had to be randomised within ~3 hours of birth. Ethical approval was granted by the East Midlands – Derby Research Ethics Committee. (BioMed Central)

Interpretation and Impact

  1. How do the results of the FEED1 Trial impact current neonatal feeding guidelines?
    Answer: The results suggest that in infants born at ~30–33 weeks’ gestation, starting full enteral milk feeds from day 1 (rather than prolonged use of IV fluids with gradual feeding) appears safe (no increased NEC/other complications) and may reduce invasive interventions and intensive-care time. This may influence neonatal feeding practice and guideline recommendations toward earlier full enteral feeding in this population. (EurekAlert!)

  2. What future research did the authors recommend following the FEED1 findings?
    Answer: The protocol and press releases mention longer-term follow-up (at 2-years corrected gestational age) planned for neurodevelopmental outcomes, and suggestion of parallel studies in other countries/settings to assess generalisability, as the trial wasn’t powered for rarer outcomes like NEC or death. (BioMed Central)

If you like, I can pull up more detailed numeric data — e.g., exact hospital stay days, subgroup analyses, growth outcomes, and full paper data tables — from the published article of FEED1. Would you like that?

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