Comparison of the Results of Premature Babies Started Complementary Feeding

NCT ID: NCT04499430

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2022-06-30

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.

Detailed Description

The transition to complementary feeding in premature babies (37 weeks and over) is recommended by both the World Health Organization (WHO) and the European Gastroenterology, Hepatology and Nutrition Association (ESPHGAN) for 4-6 months. However, a full consensus on the transition time to complementary feeding has not been achieved for premature babies. It is controversial whether premature babies (born 37th week of gestation) are corrected for complementary feeding in the sixth month or chronological sixth month. According to the known, there are no clinical studies investigating this topic in the literature.

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).

Before the transition to complementary nutrition of the groups included in the study, breast milk and / or formula food, nutritional supplement (such as breast milk enhancer, protein supplement) intake will be recorded. The same polyvitamin preparation will be used for all premature babies. In accordance with the recommendation of the World Health Organization, 2 mg / kg / day standard oral iron prophylaxis will be started to all premature babies starting from the second chronological month. Immunization will be done in accordance with the national vaccination program.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

H. Tolga Çelik

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/22555185/

complementary feeding

https://pubmed.ncbi.nlm.nih.gov/29502384/

weaning and complementary feeding in premature babies

Other Identifiers

KA-20053

Identifier Type: -

Identifier Source: org_study_id