Handling Powdered Formula and Breast Milk with Additives

 

 Reviewed by Barbara Cormack (Dietitian) and Carl Kuschel
May
2005
Clinical Guidelines Back Newborn Services Home Page
Background Recommendations for Handling of Enteral Nutrition Preparations References

Background

This guideline should apply to all infants in a neonatal unit, maternity ward, or children's hospital ward. It should also be applied to all healthy term infants for the first two months of life.

There has been recent concern about the role of powdered formula preparations in the development of Enterobacter sakazakii infection in neonates. Previously known as "yellow pigmented" Enterobacter cloacae, it was renamed Enterobacter sakazakii in 1980. It has been known to cause meningitis, septicaemia, and necrotising enterocolitis in neonates, with reported mortality rates of up to 80%.

The incidence of E.sakazakii infection is low.  In a report describing infection rates from over 10,000 VLBW infants, only one case was identified from over 6,000 blood cultures taken after the third day of life. 1  Case reports and outbreaks of E.sakazakii infection have variably been associated with the use of powdered formula. 2-9  In 2002, the FDA released a statement indicating that neonatal units should take steps to minimise the risk associated with powdered formula and additives. 10,11  In New Zealand, an investigation into a case of E.sakazakii from a New Zealand neonatal unit led to local recommendations from the Ministry of Health. 12

It is important to appreciate that powdered formulas and milk preparations are not sterile and can provide a medium for bacteria to proliferate. Appropriate preparation and handling of nutritional products is necessary to reduce the risk of milk becoming a source of nosocomial infection. 13  Breast feeding - apart from providing immunity through other means - reduces the risk of infection associated with formula preparation and storage, although care needs to be taken with breast milk which has been modified with additives.

Recommendations for Handling of Enteral Nutrition Preparations

Recommendation

Comments
Encourage the use of sterile liquid "ready to feed" formula for both healthy newborn infants in maternity wards, infants in NICU, and infants in the wards of Starship Children's Health
  • Liquid formula is sterile.
  • Although powdered formula is pasteurised, it is not sterile. Bacteria present in the formula, the preparation equipment or the containers may contaminate the preparation.
If formula needs to be prepared in advance, it should be prepared on a daily basis and should be kept at 4°C or below for not more than 30 hours
  • Refrigerate feeds on delivery to the patient care room.
  • Ensure that fridges are kept at ≤4°C and are monitored.
  • New feeds are to be delivered by every 24 hours.
    • Only enough feed for 24 hours should be delivered at one time.
  • A “use by” date and time is to be visible on every feed label.
Prepare only a small amount of reconstituted formula for each feed to reduce the quantity and time that formula is held at room temperature for consumption
  • This is not practical for most areas in the hospitals, hence the move to a liquid formula.
  • This does apply to human milk fortifier and other food additives.
    • Make up no more than 50ml (unless the infant's feed is a greater volume than this)
Minimise the "hang-time" of formula feeds (or breast milk with additives)
  • "Hang-times" should be recorded and monitored.
  • No "hang-time" should exceed 4 hours.
There should be surveillance of formula for possible contamination
  • ADHB Nutrition Services undertakes random sampling with specimens analysed by an external laboratory.
Health professionals should investigate and report sources and vehicles (including powdered infant formula) of infection by E.sakazakii and other Enterobacteriaceae
  • The Ministry of Health has indicated that Enterobacter sakazakii is a notifiable disease.

References

1 Stoll BJ, Hansen N, Fanaroff AA, et al. Enterobacter sakazakii is a rare cause of neonatal septicaemia or meningitis in VLBW infants. J Pediatr 2004;133:821-3.
2 Muytjens HL, Zanen HC, Sonderkamp HJ, Kollée LA, Wachsmuth IK, Farmer JJ 3rd.  Analysis of eight cases of neonatal meningitis and sepsis due to Enterobacter sakazakii. J Clin Microbiol 1983;18:115-20.
3 Biering G, Karlsson S, Clark NC, Jónsdóttir KE, Lúdvígsson P, Steingrímsson O.  Three cases of neonatal meningitis caused by Enterobacter sakazakii in powdered milk.  J Clin Microbiol 1989;27:2054-56.
4 Muytjens HL. Kollee LA. Enterobacter sakazakii meningitis in neonates: causative role of formula? Pediatr Infect Dis J 1990;9:372-3.
5 Jaspar AH. Muytjens HL. Kollee LA. Neonatal meningitis caused by Enterobacter sakazakii: milk powder is not sterile and bacteria like milk too! Tijdschr Kindergeneeskd 1990;58:151-5.
6 Clark NC, Hill BC, O'Hara CM, Steingrimsson O, Cooksey RC. Epidemiologic typing of Enterobacter sakazakii in two neonatal nosocomial outbreaks. Diagn Microbiol Infect Dis 1990;13:467-72.
7 Bar-Oz B, Preminger A, Peleg O, Block C, Arad I. Enterobacter sakazakii infection in the newborn. Acta Paediatr 2001;90:356-8
8 Block C, Peleg O, Minster N, et al. Cluster of neonatal infections in Jerusalem due to unusual biochemical variant of Enterobacter sakazakii. Eur J Clin Microbiol Infect Dis 2002;21:613-6.
9 van Acker J, de Smet F, Muyldermans G, Bougatef A, Naessens A, Lauwers S. Outbreak of necrotizing enterocolitis associated with Enterobacter sakazakii in powdered milk formula. J Clinical Microbiology 2001;39:293-7
10 Anonymous. Enterobacter sakazakii infections associated with the use of powdered infant formula--Tennessee, 2001. MMWR - Morbidity & Mortality Weekly Report Apr 12 2002;51(14):297-300
11 Anonymous. From the Centers for Disease Control and Prevention. Enterobacter sakazakii infections associated with the use of powdered infant formula--Tennessee, 2001. JAMA. 2002;287:2204-5.
12 Ministry of Health, New Zealand. Inquiry into Actions of Sector Agencies in Relation to Contamination of Infant Formula with Enterobacter Sakazakii. March 2005. Available online at http://www.moh.govt.nz
13 Agostoni C, Axelsson I, Goulet O, et al.  Preparation and Handling of Powdered Infant Formula: A Commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2004;39:320-2.