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Pancreatic Enzyme Replacement Therapy in Children with Severe Acute Malnutrition: A Randomized Controlled Trial
Rosalie H Bartels1, Céline Bourdon2, Isabel Potani3
1Global Child Health Group, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands; Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre, Malawi.
Insights
Pancreatic enzyme replacement therapy (PERT) did not improve weight gain in children with severe acute malnutrition. However, PERT was associated with lower mortality and a faster hospital discharge rate.
Area of Science:
- Pediatric critical care
- Nutritional science
- Gastroenterology
Background:
- Severe acute malnutrition (SAM) in children is a critical global health issue.
- Complicated SAM often involves gastrointestinal dysfunction, including exocrine pancreatic insufficiency (EPI).
- Standard care for SAM may not fully address underlying digestive impairments.
Purpose of the Study:
- To evaluate the efficacy of pancreatic enzyme replacement therapy (PERT) in improving outcomes for children with complicated SAM.
- To assess PERT's impact on weight gain, mortality, and hospital discharge rates in this vulnerable population.
Main Methods:
- A randomized controlled trial was conducted with 90 children (6-60 months) diagnosed with complicated SAM.
- The intervention group received standard care plus PERT for 28 days, while the control group received standard care alone.
- Outcomes measured included weight gain, mortality, and length of hospital stay. Fecal elastase-1 and fatty acid split ratios were assessed.
Main Results:
- Children receiving PERT did not show significant improvements in weight gain compared to controls (15.3% vs 13.7%, P=.56).
- Exocrine pancreatic insufficiency was highly prevalent (83.1%) on admission, with fecal elastase-1 levels increasing during hospitalization, particularly in non-edematous SAM.
- Mortality was significantly lower in the PERT group (18.6% vs 37.8%, P<.05), and PERT recipients had a higher likelihood of daily hospital discharge (P=.02).
Conclusions:
- PERT does not enhance weight gain in children with complicated SAM but accelerates hospital discharge.
- A notable reduction in mortality was observed with PERT, warranting further investigation in larger, stratified cohorts.
- Poor digestive function, indicated by low fecal fatty acid split ratios, is linked to mortality in SAM.
Objective:
To assess the benefits of pancreatic enzyme replacement therapy (PERT) in children with complicated severe acute malnutrition.
Study Design:
We conducted a randomized, controlled trial in 90 children aged 6-60 months with complicated severe acute malnutrition at the Queen Elizabeth Central Hospital in Malawi. All children received standard care; the intervention group also received PERT for 28 days.
Results:
Children treated with PERT for 28 days did not gain more weight than controls (13.7 ± 9.0% in controls vs 15.3 ± 11.3% in PERT; P = .56). Exocrine pancreatic insufficiency was present in 83.1% of patients on admission and fecal elastase-1 levels increased during hospitalization mostly seen in children with nonedematous severe acute malnutrition (P <.01). Although the study was not powered to detect differences in mortality, mortality was significantly lower in the intervention group treated with pancreatic enzymes (18.6% vs 37.8%; P < .05). Children who died had low fecal fatty acid split ratios at admission. Exocrine pancreatic insufficiency was not improved by PERT, but children receiving PERT were more likely to be discharged with every passing day (P = .02) compared with controls.
Conclusions:
PERT does not improve weight gain in severely malnourished children but does increase the rate of hospital discharge. Mortality was lower in patients on PERT, a finding that needs to be investigated in a larger cohort with stratification for edematous and nonedematous malnutrition. Mortality in severe acute malnutrition is associated with markers of poor digestive function.
Trial Registration:
ISRCTN.com: 57423639.
