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Effect of Peak Baby Preterm on growth and nutritional status of Nigerian late preterm infants.

The effect of Peak Baby Preterm on growth, and status of DHA, Iron, vitamin D and vitamin A in apparently healthy Nigerian late preterm infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21985
Enrollment
60
Registered
2016-12-11
Start date
2017-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth, nutritional status, apparently healthy late preterm infants, Nigeria, DHA, Iron, Vitamin A, Vitamin D

Interventions

Formula feeding versus breastfeeding

Sponsors

Department of Pediatrics, College of Medicine University of Ibadan, Ibadan, Nigeria
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: apparently healthy, appropriate for gestational age, on full enteral feeding, bottle (at least 50% at inclusion and 100% at age 4 weeks) or breastfed (at least 75% of daily milk intake) dependent on the study groups, being able and willing to drink milk, no medical recognized mental problems.

Exclusion criteria

Exclusion criteria: >50% human milk at inclusion (for the formula group) or >25% formula consumption (for the breastfed group), congenital malformations or conditions known to affect growth (e.g. severe broncho pulmonary dysplasia, inborn error of metabolism, cardiac or renal disease, necrotizing enterocolitis with substantial gut loss, and grade IV intraventricular hemorrhage), lactose intolerance, familiar history of impaired iron metabolism (haptoglobin Hp2-2, hemochromatosis, sickelcell anemia, thalassemia). Medications that may effect digestion or absorption of food, medications that may affect sleep, blood transfusions, vitamin supplements during the intervention period.

Design outcomes

Primary

MeasureTime frame
To determine the effect on growth of a newly developed preterm formula in apparently healthy Nigerian preterm born infants with a gestational age of 32-34 weeks, up to a body weight of 3500 g but at least during a period of 8 weeks. To determine the effect of the formula on blood status parameters of DHA-AA, vitamins D & A, and iron.

Secondary

MeasureTime frame
To get insight in the acceptance of the formula and breast milk by these healthy late preterm infants by using a tolerance questionnaire. To compare the effects on biochemical nutrient status parameters and growth of the preterm formula with those of breastfed infants. To get insight in the number of hospital days in both groups (formula and breast milk).

Contacts

Public ContactAnne Schaafsma

P.O.Box 226

anne.schaafsma@frieslandcampina.com+31 (0)58 2992424

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)