Comparison of the Results of Premature Babies Started Complementary Feeding

NCT04499430 | Unknown

• 1 other identifier: KA-20053
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Neurological-developmental evaluations and developmental outcomes-diagnoses of premature babies are evaluated according to corrected postnatal age. Based on the limited evidence available, it can be concluded that complementary feeding may be an appropriate age for most premature babies who have reached at least the third month, generally corrected. However, for premature babies born at different gestational weeks, these periods have a relatively different meaning. A more accurate timeframe can be found in terms of complementary nutrition by evaluating chronological age and motor development together. More prospective observational studies are needed in this regard in premature babies. In the literature, there are not enough studies on the transition time to the most appropriate complementary diet for premature babies. The investigators planned to do this prospective observational study. In this study, patient groups will be randomly selected after appropriate matching. Premature babies participating in the study will be handled in three main groups (six subgroups in total). The data will be added to the case report forms. In addition to routine follow-ups, families will be called on the phone monthly, information about their babies' nutrition will be asked, whether there is a problem, questions of families will be answered, and information about complementary nutrition will be provided. At the end of the study, all data will be collected and entered into the SPSS database, which will be created.

Conditions

Premature Birth; Feeding Behavior

Keywords

complementary feeding; prematurity

Outcome Measures

Primary Outcomes (1)

• the transition time to the most appropriate complementary diet for premature babies

  . In the literature, there are not enough studies on the transition time to the most appropriate complementary diet for premature babies. We planned to do this prospective observational study.

  24 months

Secondary Outcomes (1)

• Reaching the targeted number of patients

  24 months

Study Arms (3)

1

Group 1: 29 weeks and six days of gestation and earlier Group 1a: complementary feeding began chronologically in the sixth month Group 1b: Complementary feeding corrected at sixth month

2

Group 2: Those whose gestational age is between 30 weeks and 33 weeks and sixth days Group 2a: complementary feeding began chronologically in the sixth month Group 2b: complementary feeding started in the sixth month, corrected

3

Group 3: Those whose gestational age is between 34 weeks and 37 weeks and sixth day Group 3a: complementary feeding began chronologically in the sixth month Group 3b: complementary feeding started in the sixth month, corrected

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Group 1: 29 weeks and six days of gestation and earlier Group 2: Those whose gestational age is between 30 weeks and 33 weeks and sixth days Group 3: Those whose gestational age is between 34 weeks and 37 weeks and sixth day

You may qualify if:

• Male / female babies who were born before the mother at the Hacettepe University Children's Hospital Neonatal Intensive Care Unit and / or Hacettepe University Adult Hospital Maternity and Birth Service and were born earlier than 37 weeks.
• Babies who are at the Hacettepe University Children's Hospital Neonatal Intensive Care Unit and / or Hacettepe University Adult Hospital Maternity and Maternity Service, were born earlier than 37 weeks and continue to be followed regularly in the neonatal outpatient clinic.
• Babies whose informed consent was obtained for their participation by the family.

You may not qualify if:

• Babies with SGA (birth weight below 10th percentile according to gestational week) by birth weight
• Babies with chromosomal anomalies
• Babies diagnosed with hypoxic ischemic encephalopathy
• Babies who have had major surgical operations (gastrointestinal anomaly, severe necrotizing enterocolitis requiring surgery, major gastrointestinal system anomaly, major congenital heart anomaly, diaphragmatic hernia)
• Babies with exitus in the neonatal period
• Babies who do not continue regular polyclinic follow-up after discharge
• Babies of families who do not comply with the study protocol
• Babies with missing study data

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Links

• complementary feeding
• weaning and complementary feeding in premature babies

MeSH Terms

Conditions

Premature Birth; Feeding Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: June 8, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

TU (1)