Neutral Oligosaccharides on Reducing Enterocolitis in Preterm Infants: A Randomized Clinical Trial
One-third of the neonates exhibit intestinal perforation and colon stricture. Preterm births have a major impact on necrotizing enterocolitis in infants. This Clinical Summary captures the clinical advantage of prebiotic feed supplement in overcoming these challenges.
Background
Necrotizing enterocolitis (NEC) is a severe life-threatening condition in premature neonates. Approximately, 5-10% of preterm infants with very low birth weight (VLBW) get affected by this condition, with mortality ranging between 10-50%. Evidence suggests that Probiotics like Lactobacillus and Bifidobacterium help reduce intestinal inflammation and NEC incidence. Moreover, oligosaccharides (prebiotics) are present in breast milk which inhibit the binding of a pathogen with gastrointestinal epithelial cells and also stabilize the growth of Bifidobacterium, which contribute to the reduction of pathogenic microflora in the intestine.
Aim
The clinical trial evaluated the efficacy of a prebiotic mixture of short-chain galacto-oligosaccharides/long-chain fructo-oligosaccharides (SCGOS/LCFOS) to reduce NEC incidence in preterm infants with VLBW.
Subject selection and inclusion criteria
- Duration of the study: Study conducted over 1 year span from December 2012- November 2013.
- Subject: 75 preterm infants [gestational age (GA) ≤ 34 weeks].
- Birth weight: ≤ 1.5 kg
- Study groups: Randomly divided into two groups (prebiotic: control=2:1), with or without prebiotic mixture of SCGOS/LC FOS; 9:1
- Average GA and body weight:
- Prebiotic group - Average GA: 30.48 ± 2.31 weeks, body weight: 1262.80 ± 213.35 g
- Control group - Average GA: 30.38 ± 2.53 weeks, body weight: 1205.60 ± 177.23 g.
Table 1 explains the dose alteration ratio of prebiotic mixture according to the breast milk intake.
Table 1: Relation between breast milk intake and prebiotic dose.
|
Milk
intake (ml/kg/day) |
Probiotic
dose (g/kg/day) |
|
30-70 |
0.5 |
|
70-110 |
1 |
|
110-150 |
1.5 |
|
After
their milk intake volume exceeded 150 ml/kg/day, the prebiotic dose was
continued for extra two days |
|
Primary & secondary outcomes
- To evaluate the effect of SCGOS/LCFOS mixture on NEC occurrence.
- To determine the tolerability of prebiotic, and to understand it’s effect on sepsis, age of full enteral feeding achievement, duration of hospitalization, sepsis and death of the neonates.
Results
The trial results showed that the prebiotic (SCGOS/LCFOS) supplementation reduced the incidence of NEC, and duration of hospitalization in preterm VLBW infants who were exclusively fed with breast-milk.
The study reported that ten neonates developed suspected NEC in the control group, and one neonate developed proven NEC. However, in the prebiotic group, only one neonate had symptoms of NEC. Interestingly, the use of prebiotics was also associated with decreased hospitalization time and a reduced timeline for full enteral feeding. Table 2 explains the efficacy of prebiotic mixture in VLBW preterm infants.
Table 2: Important outcomes of the clinical trial
|
Outcome |
Prebiotic group (n= 25) |
Control group (n= 25) |
Hazard ratio (95% CI) |
Significance |
|
NEC |
1 |
11 |
0.49 (0.29-0.84) |
P= 0.009 |
|
Sepsis |
4 |
17 |
0.60 (0.27-
2.72) |
Not significant |
|
Requiring to milk cut-off |
9 |
28 |
0.63 (0.29-1.38) |
Not significant |
|
Duration of hospitalization [median(range)] |
16 (9-45) days |
25 (11-80) days |
NA |
P = 0.004 |
|
Time to full enteral feeds [median(range)] |
11 (7-21) |
14 (8-36) |
NA |
P = 0.02 |
|
Side effect |
0 |
0 |
NA |
NA |
|
Death |
1 |
1 |
NA |
Not significant |
CI: Confidence Interval; NA: Not Applicable
Conclusion
SC GOS/LC FOS; 9:1 is a well-tolerated prebiotic for infants.
Enteral supplements of prebiotic significantly reduce the incidence of NEC in VLBW preterm infants.
Prebiotic feed supplement significantly decreases the time of hospital stay and time to full enteral feeding.
References:
- Armanian AM, Sadeghnia A, Hoseinzadeh M, et al. The Effect of Neutral Oligosaccharides on Reducing the Incidence of Necrotizing Enterocolitis in Preterm infants: A Randomized Clinical Trial. Int J Prev Med. 2014;5(11):1387-1395.
IMPORTANT NOTICE:
MOTHER’S MILK IS BEST FOR YOUR BABY
The World Health Organization (WHO)* has recommended that pregnant women and new mothers be informed of the benefi¬ts and superiority of breast-feeding, in particular, the fact that it provides the best nutrition and protection from illness for babies. Mothers should be given guidance on the preparation for and maintenance of lactation, with special emphasis on the importance of the well-balanced diet both during pregnancy and after delivery. Unnecessary introduction of partial bottle feeding or other foods and drinks should be discouraged since it will have a negative effect on breast-feeding. Similarly, mothers should be warned of the diffi¬culty of reversing a decision not to breastfeed. Before advising a mother to use an infant formula, she should be advised of the social and ¬financial implications of her decision. For example, if a baby is exclusively bottle-fed, more than one can (500g) per week will be needed, so the family circumstances and cost should be kept in mind. Mother should be reminded that breast milk is not only the best but also the most economical food for babies. If a decision to use infant formula is taken, it is important to give instruction on correct preparation methods, emphasizing that unboiled water, unsterilized bottles or incorrect dilution can lead to illness.
*See: International Code of Marketing of Breast Milk Substitutes, adopted by the World Health Assembly in Resolution WHA 34.22, May 1981.
Importance of Breastfeeding:
Immediately after delivery, breast milk is yellowish and sticky. This milk is called colostrum, which is secreted during the fi¬rst week of delivery. Colostrum is more nutritious than mature milk because it contains more protein, more anti-infective properties which are of great importance for the infant's defense against dangerous neonatal infections. It also contains higher levels of, Vitamin 'A', (ii) breast miIk- A) is, a complete and balanced food and provides all the nutrients needed by the infant [for the ¬first six months of life] (B) has anti-infective properties that protect the infants from infection in the early months (C) is always available; (D) needs no utensils or water (which might, carry germs) or fuel for its preparation, (iii) breastfeeding is much cheaper than feeding infant milk substitutes as the cost of the extra food needed by the mother is negligible compared to the cost of feeding infant milk substitutes, (iv) mothers who breast-feed usually have longer periods of infertility after child birth than non-lactators; (b) details of management of breast feeding, as under:- (i) breast-feeding- (A) immediately after delivery enables the contraction of the womb and helps the mother to regain her ¬figure quickly; (B) is successful when the infant suckles frequently and the mother wanting to breast-feed is confi¬dent in her ability to do so (ii) in order to promote and support breast-feeding the mother’s natural desire to breast feed should always be encouraged by giving, where needed, practical advice and making sure that she has the support of her relatives. (iii) adequate care for the breast and nipples should be taken during pregnancy. (iv) it is also necessary to put the infant to the breast as soon as possible after delivery, (v) let the mother and the infant stay together after the delivery, the mother and her infant should be allowed to stay together (in hospital, this is called "rooming-in"); (vi) give the infant colostrum as it is rich in many nutrients and anti-infective factors protecting the infants from infections during the few days of its birth; (vii) the practice of discarding colostrum and giving sugar water, honey water, butter or other concoctions instead of colostrum should be very strongly discouraged; (viii) let the infants suckle on demand; (ix) every effort should be made to breast-feed the infants whenever they cry; (x) mother should keep her body and clothes and that of the infant always neat and clean.
Breast-feeding is the best form of nutrition for babies and provides many benefi¬ts to babies and mothers. It is important that, in preparation for and during breast-feeding, you eat a healthy, balanced diet. Combined breast and bottle-feeding in the ¬first weeks of life may reduce the supply of your own breast-milk and reversing the decision not to breast-feed is dif¬ficult.
Always consult your Healthcare Professional for advice about feeding your baby. The social and fi-nancial implications of using infant formula should be considered. Improper use of an infant formula or inappropriate foods or feeding methods may present a health hazard. If you use infant formula, you should follow manufacturer's instructions for use carefully - failure to follow the instructions may make your baby ill.
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