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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Early total enteral feeding versus conventional incremental feeding in preterm infants weighing 1000-1250 g: a
Anuradha Mishra1, Soumya Jyoti Raha2, Jogender Kumar2
1Department of Pediatrics, VMMC & Safdarjung Hospital, New Delhi, India.
Insights
Early total enteral feeding (ETEF) in preterm infants did not speed up achieving full enteral feeds. However, ETEF led to earlier birth weight regain and reduced intravenous fluid use without increasing complications.
Area of Science:
- Neonatalogy
- Pediatric Gastroenterology
- Clinical Nutrition
Background:
- Early total enteral feeding (ETEF) may decrease reliance on parenteral nutrition and intravenous fluids in preterm infants.
- Evidence for ETEF's safety and efficacy is limited in preterm infants weighing 1000-1250g.
Purpose of the Study:
- To compare the safety and effectiveness of ETEF versus conventional enteral feeding (CEF) in preterm infants with birth weights of 1000-1250g.
Main Methods:
- A single-center, open-label randomized controlled trial involving preterm infants (≤34 weeks gestation, 1000-1250g birth weight).
- Infants were randomized to ETEF (80 mL/kg/day from day 1) or CEF (30 mL/kg/day with IV fluids/PN).
- Primary outcome: time to full enteral feeding (150 mL/kg/day); secondary outcomes: feed intolerance, NEC, sepsis, mortality, time to regain birth weight, and IV fluid duration.
Main Results:
- The median time to achieve full enteral feeding was similar between ETEF and CEF groups (6.5 days in both).
- Infants in the ETEF group regained birth weight earlier (16 vs. 18.5 days; p=0.008) and had a shorter duration of intravenous fluid therapy (3 vs. 6 days; p<0.001).
- No significant differences were found in feed intolerance, necrotizing enterocolitis (NEC), sepsis, or mortality between groups.
Conclusions:
- ETEF did not shorten the time to achieve full enteral feeding compared to CEF in preterm infants weighing 1000-1250g.
- ETEF was associated with earlier regain of birth weight and reduced need for intravenous fluids.
- ETEF did not increase the incidence of feed intolerance, NEC, sepsis, or mortality.
Abstract:
Early total enteral feeding (ETEF) may reduce exposure to intravenous fluids and parenteral nutrition in preterm infants. However, evidence regarding its safety and effectiveness remains limited, particularly among preterm infants with a birth weight of 1000-1250 g. We compared ETEF with conventional enteral feeding (CEF) in this population. In this single-center, open-label, randomized controlled trial, preterm infants (≤ 34 weeks' gestation) with birth weights of 1000-1250 g were randomized to ETEF (80 mL/kg/day enteral feeds from day 1; n = 87) or CEF (30 mL/kg/day enteral feeds with intravenous fluid or parenteral nutrition; n = 83). The primary outcome was time to attain full enteral feeding (150 mL/kg/day). Secondary outcomes included feed intolerance, necrotizing enterocolitis (NEC), sepsis, mortality, time to regain birth weight, and duration of intravenous fluid. A total of 170 infants were randomized and followed up. The median (IQR) time to attain full enteral feeds was similar between the ETEF and CEF groups (6.5[5-10] vs. 6.5[5-11] days; p=0.40). Infants receiving ETEF regained birth weight earlier (16[11.5-19] vs. 18.5[13.8-26] days; p=0.008) and required intravenous fluid for a shorter duration (3[0-6] vs. 6[4-9] days; p<0.001). Feed intolerance, NEC, sepsis, hospital stay, and mortality were comparable between the two groups.
Conclusion:
Early total enteral feeding did not improve the time to achieve full enteral feeding compared with CEF. However, ETEF was associated with earlier regain of birth weight and reduced duration of intravenous fluid therapy. No statistically significant differences were observed in feed intolerance, NEC, sepsis, or mortality.
Trial Registration:
CTRI/2022/09/045974.
What Is Known:
• Early total enteral feeding may reduce the dependence on parenteral nutrition and intravenous fluid in preterm infants. • Large multicentre evidence now supports feasibility in clinically stable infants born at 30 to 32+6 weeks, but evidence remains limited for VLBW infants and high-morbidity NICU populations.
What Is New:
• In preterm infants with birth weight 1000-1250 g, early total enteral feeding did not shorten the time to full enteral feeding compared with conventional feeding. • Early total enteral feeding was associated with earlier regaining of birth weight and a lesser need for intravenous fluid therapy without increasing feed intolerance, necrotizing enterocolitis, sepsis, or mortality.
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