Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age—A randomized controlled trial
ObjectivesWe aimed to compare the effects of nutrient-enriched formula with standard term formula on rate of body weight gain of late preterm infants appropriately grown for gestational age.Study designA multi-center, randomized, controlled trial. Late preterm infants (34–37 weeks' gestation),...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-05-01
|
| Series: | Frontiers in Pediatrics |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2023.1146089/full |
| _version_ | 1797835596798885888 |
|---|---|
| author | Karen P. Best Karen P. Best Lisa N. Yelland Lisa N. Yelland Carmel T. Collins Carmel T. Collins Andrew J. McPhee Geraint B. Rogers Geraint B. Rogers Jocelyn Choo Jocelyn Choo Robert A. Gibson Robert A. Gibson Teresa Murguia-Peniche Teresa Murguia-Peniche Jojy Varghese Timothy R. Cooper Maria Makrides Maria Makrides |
| author_facet | Karen P. Best Karen P. Best Lisa N. Yelland Lisa N. Yelland Carmel T. Collins Carmel T. Collins Andrew J. McPhee Geraint B. Rogers Geraint B. Rogers Jocelyn Choo Jocelyn Choo Robert A. Gibson Robert A. Gibson Teresa Murguia-Peniche Teresa Murguia-Peniche Jojy Varghese Timothy R. Cooper Maria Makrides Maria Makrides |
| author_sort | Karen P. Best |
| collection | DOAJ |
| description | ObjectivesWe aimed to compare the effects of nutrient-enriched formula with standard term formula on rate of body weight gain of late preterm infants appropriately grown for gestational age.Study designA multi-center, randomized, controlled trial. Late preterm infants (34–37 weeks' gestation), with weight appropriate for gestational age (AGA), were randomized to nutrient enriched formula (NEF) with increased calories (22 kcal/30 ml) from protein, added bovine milk fat globule membrane, vitamin D and butyrate or standard term formula 20 kcal/30 ml (STF). Breastfed term infants were enrolled as an observational reference group (BFR). Primary outcome was rate of body weight gain from enrollment to 120 days corrected age (d/CA). Planned sample size was 100 infants per group. Secondary outcomes included body composition, weight, head circumference and length gain, and medically confirmed adverse events to 365 d/CA.ResultsThe trial was terminated early due to recruitment challenges and sample size was substantially reduced. 40 infants were randomized to NEF (n = 22) and STF (n = 18). 39 infants were enrolled in the BFR group. At 120 d/CA there was no evidence of a difference in weight gain between randomized groups (mean difference 1.77 g/day, 95% CI, −1.63 to 5.18, P = 0.31). Secondary outcomes showed a significant reduction in risk of infectious illness in the NEF group at 120 d/CA [relative risk 0.37 (95% CI, 0.16–0.85), P = 0.02].ConclusionWe saw no difference in rate of body weight gain between AGA late preterm infants fed NEF compared to STF. Results should be interpreted with caution due to small sample size.Clinical Trial RegistrationThe Australia New Zealand Clinical Trials Registry (ACTRN 12618000092291). “mailto:maria.makrides@sahmri.com” maria.makrides@sahmri.com. |
| first_indexed | 2024-04-09T14:56:09Z |
| format | Article |
| id | doaj.art-34662f1a40d84183a05e44e74802ea66 |
| institution | Directory Open Access Journal |
| issn | 2296-2360 |
| language | English |
| last_indexed | 2024-04-09T14:56:09Z |
| publishDate | 2023-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pediatrics |
| spelling | doaj.art-34662f1a40d84183a05e44e74802ea662023-05-02T05:08:07ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602023-05-011110.3389/fped.2023.11460891146089Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age—A randomized controlled trialKaren P. Best0Karen P. Best1Lisa N. Yelland2Lisa N. Yelland3Carmel T. Collins4Carmel T. Collins5Andrew J. McPhee6Geraint B. Rogers7Geraint B. Rogers8Jocelyn Choo9Jocelyn Choo10Robert A. Gibson11Robert A. Gibson12Teresa Murguia-Peniche13Teresa Murguia-Peniche14Jojy Varghese15Timothy R. Cooper16Maria Makrides17Maria Makrides18Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, SA, AustraliaAdelaide Medical School, The University of Adelaide, Adelaide, SA, AustraliaWomen and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, SA, AustraliaSchool of Public Health, The University of Adelaide, Adelaide, SA, AustraliaWomen and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, SA, AustraliaAdelaide Medical School, The University of Adelaide, Adelaide, SA, AustraliaWomen and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, SA, AustraliaLifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, SA, AustraliaInfection and Immunity, Flinders Health and Medical Research Institute, College of Medicine and Public Health, Flinders University, Bedford Park, SA, AustraliaLifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, SA, AustraliaInfection and Immunity, Flinders Health and Medical Research Institute, College of Medicine and Public Health, Flinders University, Bedford Park, SA, AustraliaWomen and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, SA, AustraliaSchool of Agriculture, Food and Wine, University of Adelaide, Adelaide, SA, AustraliaSchool of Medicine, Indiana University, Evansville, IN, United StatesMedical Sciences, Mead Johnson Nutrition|Reckitt, Evansville, IN, United StatesDepartment of Neonatology, Lyell McEwin Hospital, Adelaide, SA, AustraliaMedical Sciences, Mead Johnson Nutrition|Reckitt, Evansville, IN, United StatesWomen and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, SA, AustraliaAdelaide Medical School, The University of Adelaide, Adelaide, SA, AustraliaObjectivesWe aimed to compare the effects of nutrient-enriched formula with standard term formula on rate of body weight gain of late preterm infants appropriately grown for gestational age.Study designA multi-center, randomized, controlled trial. Late preterm infants (34–37 weeks' gestation), with weight appropriate for gestational age (AGA), were randomized to nutrient enriched formula (NEF) with increased calories (22 kcal/30 ml) from protein, added bovine milk fat globule membrane, vitamin D and butyrate or standard term formula 20 kcal/30 ml (STF). Breastfed term infants were enrolled as an observational reference group (BFR). Primary outcome was rate of body weight gain from enrollment to 120 days corrected age (d/CA). Planned sample size was 100 infants per group. Secondary outcomes included body composition, weight, head circumference and length gain, and medically confirmed adverse events to 365 d/CA.ResultsThe trial was terminated early due to recruitment challenges and sample size was substantially reduced. 40 infants were randomized to NEF (n = 22) and STF (n = 18). 39 infants were enrolled in the BFR group. At 120 d/CA there was no evidence of a difference in weight gain between randomized groups (mean difference 1.77 g/day, 95% CI, −1.63 to 5.18, P = 0.31). Secondary outcomes showed a significant reduction in risk of infectious illness in the NEF group at 120 d/CA [relative risk 0.37 (95% CI, 0.16–0.85), P = 0.02].ConclusionWe saw no difference in rate of body weight gain between AGA late preterm infants fed NEF compared to STF. Results should be interpreted with caution due to small sample size.Clinical Trial RegistrationThe Australia New Zealand Clinical Trials Registry (ACTRN 12618000092291). “mailto:maria.makrides@sahmri.com” maria.makrides@sahmri.com.https://www.frontiersin.org/articles/10.3389/fped.2023.1146089/fullpretermnutritioninfant feedingnutrient enriched formulainfant growthlate preterm |
| spellingShingle | Karen P. Best Karen P. Best Lisa N. Yelland Lisa N. Yelland Carmel T. Collins Carmel T. Collins Andrew J. McPhee Geraint B. Rogers Geraint B. Rogers Jocelyn Choo Jocelyn Choo Robert A. Gibson Robert A. Gibson Teresa Murguia-Peniche Teresa Murguia-Peniche Jojy Varghese Timothy R. Cooper Maria Makrides Maria Makrides Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age—A randomized controlled trial Frontiers in Pediatrics preterm nutrition infant feeding nutrient enriched formula infant growth late preterm |
| title | Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age—A randomized controlled trial |
| title_full | Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age—A randomized controlled trial |
| title_fullStr | Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age—A randomized controlled trial |
| title_full_unstemmed | Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age—A randomized controlled trial |
| title_short | Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age—A randomized controlled trial |
| title_sort | growth of late preterm infants fed nutrient enriched formula to 120 days corrected age a randomized controlled trial |
| topic | preterm nutrition infant feeding nutrient enriched formula infant growth late preterm |
| url | https://www.frontiersin.org/articles/10.3389/fped.2023.1146089/full |
| work_keys_str_mv | AT karenpbest growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT karenpbest growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT lisanyelland growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT lisanyelland growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT carmeltcollins growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT carmeltcollins growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT andrewjmcphee growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT geraintbrogers growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT geraintbrogers growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT jocelynchoo growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT jocelynchoo growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT robertagibson growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT robertagibson growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT teresamurguiapeniche growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT teresamurguiapeniche growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT jojyvarghese growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT timothyrcooper growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT mariamakrides growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial AT mariamakrides growthoflatepreterminfantsfednutrientenrichedformulato120dayscorrectedagearandomizedcontrolledtrial |