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Completed

NCT Number: NCT05009823

Dietary Rehabilitation in Severely Acutely Malnourished Children

Severe acute malnutrition (SAM) is a life threatening condition and is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 World Health Organization (WHO) growth standards, 2) a mid-upper arm circumference (MUAC) of less than 115 mm or 3) by the presence of nutritional edema. Signs such as edema, mucocutaneous changes, hepatomegaly, lethargy, anorexia, anemia, severe immune deficiency and rapid progression to mortality characterize a state commonly coined as "complicated SAM". Kwashiorkor is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. SAM results in high mortality rates of up to half a million child deaths annually. Undernourished children are at higher risk of mortality ranging from three-times more risk among children with moderate malnutrition to 10-times in SAM children compared to well-nourished children. Children with complicated SAM require inpatient treatment in specialized centers.

The "Rehabilitation and Nutritional Education Center" (CREN) is a specialized center in Burkina Faso receiving on average 10 SAM children per day. Recovery rate is lower than international standards; and adverse events and mortality remain strikingly high.

The main objective of this study is to assess the underlying risk factors affecting the effectiveness of the nutritional therapeutic treatment protocol for complicated SAM children under 5 years of age who have been referred to the CREN, at the Centre Hôspitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.

The specific objective of this study is to better understand underlying risk factors associated with a lower recovery rate and high mortality in complicated SAM children referred to CREN for inpatient care. Risk factors associated with poor response to a standard dietary treatment at any phase will be assessed retrospectively.

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Key information

Age range

0 month–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Souro

Bobo-Dioulasso, Burkina Faso

About this study

Severe acute malnutrition (SAM), defined as severe wasting [weight-to-height Z-score < -3 standard deviations (SD), based on the WHO Child Growth Standards] and / or the presence of nutritional edema, and / or mid-upper arm circumference (MUAC) <115 mm, is a condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. Management of SAM children without complications is provided at the community level. Hospitalization in specialized care centers is necessary for SAM children with complications. SAM children with comorbidities have a greater risk of mortality and treatment failure. The knowledge of the specific adequate nutritional needs of SAM is limited.

For the treatment of SAM in hospital, the WHO recommends the use of therapeutic milk low in protein 'F75' in the stabilization phase; and more protein-rich F100 or F75 combined with ready-to-use therapeutic foods (RUTF) in the transition phase. The WHO also recommends using as an alternative formula made of cereal flour, skimmed milk powder, oil, sugar, and a therapeutic vitamin and mineral complex (CMV), in case of shortage of the standard therapeutic milk F75 / F100 or in case of signs of intolerance (vomiting, diarrhea).

The Refeeding Center - Centre de Récupération et d'Education Nutritionnelle (CREN) of the Sourô Sanou University Hospital Center (CHUSS) in Burkina Faso specializes in the care of SAM children with complications. In 2018, out of 500 children aged 6-59 months admitted for SAM with complications, the CHUSS CREN registered 86.8% full recovery, 8.2% dropout and 5% death. Although the recovery rate is higher than international standards (greater than 75%), the mortality rate remains higher than the recommended 3% by international standards; in addition to the challenges that are faced locally in maintaining high standards of care. At the CREN, the investigators and the nurses observed that some SAM children with complications can have severe diarrhea and vomiting after taking F75 (first phase of the nutritional treatment). It was also observed that other SAM children with edema, whose edema resolved in the first phase of treatment under F75, redeveloped edema when they received RUTF (Plumpy Nut®) in the transition phase according to the WHO 2013 protocol.

This research project, which will be subdivided into a retrospective study and two prospective clinical trials aims to assess the risk factors affecting the response to dietary treatment in this center (the CREN, Burkina Faso) and to compare alternatives for treatment during the nutritional rehabilitation.

The retrospective study assesses the factors of failure of dietary treatment in the three phases of nutritional rehabilitation to better understand underlying risk factors associated with a lower recovery rate and high mortality in complicated SAM children referred to CREN for inpatient care. Risk factors associated with poor response to a standard dietary treatment at any phase will be assessed retrospectively and include:

  • Errors in the treatment (feeding) dosage that can be due to errors in anthropometric measurement and/or in reading the feeding regimen table by the CREN team;
  • Low adherence of children to the therapeutic dietary regimen
  • Comorbidities associated with malnutrition that can have an effect on the dietary treatment effectiveness
  • Types of dietary regimen selected during the first phase of treatment [F75 vs. alternative F75 (cereal flour, oil, sugar, powdered milk) with OR without CMV)] and during the transition phase [F75 + RUTF ( Plumpy-Nut®), F100, alternative F75 (with and without CMV) + RUTF (Plumpy Nut®)].

The study will use data collected during admission and follow-up of SAM children with complications admitted at the CREN of the CHUSS from January 2014 to December 2018.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe acute malnutrition defined as Weight-for-Height Z-score (WHZ) <- 3 SD AND / OR MUAC <115 mm AND / OR with edema
  • With complications
  • Who were admitted and treated in the refeeding center (CREN) of the CHUSS from January 2014 TO December 2018
  • Aged between 0 and 59 Months

Exclusion criteria

  • Older than 59 Months
  • Moderate Acute Malnutrition (MAM)

Treatment and study plan

Standard F75

Dietary Supplement

F-75 contains 75 kcal and 0.9 g protein per 100 ml.

Alternative F75 with CMV

Dietary Supplement

Cereal flour, oil, sugar, powdered milk with complex mineral-vitamin.

Alternative F75 without CMV

Dietary Supplement

Cereal flour, oil, sugar, powdered milk without complex mineral-vitamin.

F100

Dietary Supplement

100 kcal and 3 g protein per 100 ml if the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut)

Standard F75 + RUTF

Dietary Supplement

Standard F75 with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive

Alternative F75 with CMV + RUTF

Dietary Supplement

Alternative F75 + CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 + CMV during the stabilization phase

Alternative F75 without CMV + RUTF

Dietary Supplement

Alternative F75 - CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 - CMV during the stabilization phase

Primary outcomes

  1. Number of days during the first phase of treatment

    Time frame: Three to Seven days

    Average number of days spent in the stabilization phase in Days

  2. Number of days during the transition phase of treatment

    Time frame: Three to Five days

    Average number of days spent in the transition phase in Days

  3. Daily weight gain during the first phase of treatment

    Time frame: Three to Seven days

    Average daily weight gain in the stabilization phase in Grams

  4. Daily weight gain during the transition phase

    Time frame: Three to Five days

    Average daily weight gain in the transition phase in Grams

  5. Edema redevelopment during the transition phase

    Time frame: Three to Five days

    Edema redevelopment during the transition phase after starting to resolve during the stabilizing phase.

Secondary outcomes

  1. Anorexia

    Time frame: Through study completion, an average of 15 days

    Serious severe event that occurs at anytime during the treatment

  2. Mortality

    Time frame: Through study completion, an average of 15 days

    Serious severe event that occurs at anytime during the treatment

  3. Diarrhea

    Time frame: Through study completion, an average of 15 days

    Serious severe event that occurs at anytime during the treatment

  4. Vomiting

    Time frame: Through study completion, an average of 15 days

    Serious severe event that occurs at anytime during the treatment

  5. Adherence to the dietary treatment

    Time frame: Through study completion, an average of 15 days

    Daily intake of the administered dietary treatment

Other outcomes

  1. HIV/AIDS

    Time frame: Through study completion, an average of 15 days

    Detection of HIV/AIDS using polymerase chain reaction (PCR) in infants and children younger than 18 months or retroviral serology test in older children

  2. Hepatitis

    Time frame: Through study completion, an average of 15 days

    Test of hepatitis

  3. Tuberculosis

    Time frame: Through study completion, an average of 15 days

    Test of tuberculosis

  4. Tumoral pathologies (benign or malignant)

    Time frame: Through study completion, an average of 15 days

    Clinical diagnosis

  5. Malformative pathologies

    Time frame: Through study completion, an average of 15 days

    Clinical diagnosis

  6. Diabetes

    Time frame: Through study completion, an average of 15 days

    Clinical diagnosis

  7. Renal failure.

    Time frame: Through study completion, an average of 15 days

    Clinical diagnosis

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Centre Muraz
  • Institut de Recherche en Sciences de la Sante, Burkina Faso
  • University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso)

Registry information

Official study title

The Underlying Causes Affecting the Response to Dietary Rehabilitation in Severely Acutely Malnourished Children at the Center Hôspitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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