Late and moderately preterm infants Neonatal Diseases Other preterm infants
Conditions
Interventions
Please note that infants are first recruited to an observational cohort. From within this cohort infants who are eligible will be enrolled to an RCT. Outcomes are the same for both groups.
Infants wi
Sponsors
Newcastle Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
0 Weeks to 37 Weeks
Inclusion criteria
Inclusion criteria: 1. Healthy moderate to late preterm infants (gestational age = 32 and = 36 6/7 weeks) 2. Age at inclusion = term equivalent age 3. Birth weight between 1.25-2.5 kg 4. Infants who are predominantly formula fed (max. 1 breastfeeding per day) using a standard term infant formula 5. Written informed consent from parent(s) and/or legal guardian, aged = 18 years, to be enrolled into a randomised trial
Exclusion criteria
Exclusion criteria: 1. Any gastrointestinal, congenital or other problem likely to affect growth and nutrition, or requiring use of specialised milk formula or other diet e.g. due to confirmed allergy; or where the attending medical team feel that trial participation is inappropriate for any other medical condition 2. Ongoing child protection procedures or maternal drug misuse requiring social services involvement 3. Family circumstances where follow-up not likely to be possible e.g. family travel abroad for prolonged periods, or where it appears likely that the family will be unable to comply with the necessary research visits 4. Participation in another interventional study that may potentially confound or interact with this study 5. Family unable to understand English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily weight gain from randomisation until 3 months corrected age. Weight measured using standard weighing scales at baseline, discharge, term equivalent age (TEA), 3,6,12 and 24 months corrected age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Growth (weight, length and head circumference) from term equivalent age (TEA) until 3 months. Length and head circumference are measured using standard linear length boards and head circumference using non-stretchable tape measures at term and 3 months corrected age 2. Body composition measured by Dual X-Ray Absorptiometry (DEXA) before/at term and 3 months corrected age. DEXA will provide lean body mass, total body fat mass, % fat and lean body mass, fat mass index, fat free mass index, bone mineral density, bone mineral content, ulna and lower leg length 3. Anthropometry: weight, length, head, mid-upper arm and mid-thigh circumference (using tapes) at baseline, discharge, term equivalent age (TEA), 3,6,12 and 24 months 4. Skinfold thicknesses using Harpenden calipers: triceps, biceps, supra-iliac, subscapular at baseline, discharge, term equivalent age (TEA), 3,6,12 and 24 months 5. Arm muscle area, arm fat area and arm fat % calculated from mid-upper arm circumference and triceps skinfolds 6. WHO Z-scores of anthropometric parameters at baseline, discharge, term equivalent age (TEA), 3, 6, 12 and 24 months: 6.1. Weight-for-age z scores 6.2. Weight-for-length z scores 6.3. Length-for-age z scores 6.4. Body Mass Index-for-age (BMI-for-age) z scores. BMI is automatically calculated from weight divided by height squared [kg/m2] 6.5. Head circumference-for-age z scores 6.6. Mid-upper arm circumference-for-age z scores (from 3 months corrected age onwards) 6.7. Skinfold-for-age z-scores (subscapular, triceps; from 3 months corrected age onwards) 7. Gain in above mentioned growth and body composition parameters and (when applicable) their z-scores during the study, including at least the following time intervals: randomization/term to 3 months corrected age, randomization/term to 6 months corrected age, 6 to 12 months of corrected age and 12 to 24 months corrected age 8. Number, type and severity of (serious) adverse events up to 12 months of corrected age 9. Nu | — |
Countries
England, United Kingdom
Outcome results
None listed