About this trial
Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds. ELBW infants initially remained NPO for several days before initiating trophic feeds. However, data then showed that there was no increase in mortality and morbidity if trophic feeds were initiated earlier. Then data showed that a short duration of trophic feeds did not increase mortality and morbidity when compared to a prolonged duration. More recent data showed that enteral feeding should be initiated early, preferably within 24 hours of birth, because it may promote feeding tolerance, shorten the time to reach total enteral feeding, and reduce the incidence of extrauterine growth restriction and late onset sepsis without increasing the risk of developing NEC. The management of enteral nutrition in ELBW infants is still very variable. For example, there is no consensus on the optimal time point after birth at which enteral nutrition can be started. This study evaluates the benefits of starting feeds by 6 hours of life Purpose: The primary aim of this study is to evaluate if in infants ≤ 1000g birth weight, is there a benefit initiating feeds by 6 hours of life (compared to current feeding practice data of 3 days of life) on decreasing the time to attain full feeds in the first 30 days of life. The secondary aim is to evaluate if antenatal feeding discussions would streamline feeding management post-delivery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All infants less than or equal to 1000 g
Clinical care team in agreement with patient's participation
All mothers with pregnancies with EFW close to 1000g or less.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Starting feeds within 6 hours of life
Other interventionStarting feeds within 6 hours of life
Standard feeding protocol
Other interventionStarting feeds based on standard protocol as per primary team
Treatment groups
Trial outcomes
Primary outcomes
Day of life reaching full feeds
The primary outcome is the age in days in the first 30 days of life when the infant reaches full feeds.
Secondary outcomes
Secondary Outcomes
Days of central line use (Days)
Secondary Outcomes
Days of TPN use (Days)
Secondary Outcomes
The number of feeding intolerance events defined as feedings held for \>24 hours per clinician judgment due to gastrointestinal symptoms such as emesis, abdominal distention, etc.
Secondary Outcomes
The development of BPD (Y/N)
Sponsors and contacts
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