A multi-centre safety and efficacy trial of a preterm infant formula supplemented with long chain polyunsaturated fatty acids (LCP) (48 weeks PCA analysis)
West Indian med. j
; West Indian med. j;47(Suppl. 3): 24-5, July 1998.
Article
em En
| MedCarib
| ID: med-1725
Biblioteca responsável:
JM3.1
Localização: JM3.1; R18.W4
ABSTRACT
LCP supplementation of premature infant formula has been shown to produce plasma and erythrocyte lipid profiles similar to human milk (HM)-fed preterm infants. Previous studies reported decreased growth with LCP supplemented formula. This prospective, double-blind, randomised, controlled, parallel trial compared safety, growth and phospholipid fatty acid (PFA) levels in preterm infants fed preterms formula with (L+) or without (Lo) LCP. The study consisted of Phase I enrolment to 40 weeks (wk) postconceptual age (PCA); and Phase II 40 to 48 wk PCA. Infants (birth weight 750-2000 g, 0-28 days of age) were fed L+ or L preterm formula, 24 Kcal/oz during Phase I, and 20 Kcal/oz during Phase II. A control group was exclusively HM-fed preterms who, if weaned at the end of Phase I, received L. HM and formula intake were unrestricted. Weight (wt), length (Lt), head circumference (OFC) and upper mid-arm circumference (MAC), and phospholipid profiles were measured at 40 and 48 wk PCA. Adverse events were monitored. 183/288 infants completed Phase II. There were no difference in growth rates between formula groups. At 48 wk PCA, mean PFA levels in infants fed L+ were similar to HM-fed and were significantly higher than the L fed group. Adverse events were similar between the 2 formula groups. The number of infants who were discontinued because of an adverse event was similar among all groups. In conclusion the LCP preterm infant formula is safe, support normal growth and maintains phospholipid profiles similar to HM-fed infants.(AU)
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Coleções:
01-internacional
Base de dados:
MedCarib
Assunto principal:
Ácidos Graxos Insaturados
/
Alimentos Infantis
Tipo de estudo:
Clinical_trials
Limite:
Humans
/
Infant
Idioma:
En
Revista:
West Indian med. j
Ano de publicação:
1998
Tipo de documento:
Article