Premature BirthCOTROPBSCFNCT04499430
Comparison of the Results of Premature Babies Started Complementary Feeding
An observational study of Premature Birth and Feeding Behavior, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Premature Birth, Feeding Behavior
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2020to 30 Jun 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Results of Premature Babies Started Complementary Feeding in Adjusted or Chronologically in Their Sixth Month
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.
Read the 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
- Keywords
- complementary feeding, prematurity
- Medical subject headings
- Premature Birth, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
Reaching the targeted number of patients
In this time we aim to reach the targeted number of patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start8 Jun 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Tolga Çelik, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499430
- Sponsor's protocol ID
- KA-20053
- Acronym
- COTROPBSCF
- Status last verified
- Aug 2020
- First submitted
- 31 Jul 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Results of Premature Babies Started Complementary Feeding in Adjusted or Chronologically in Their Sixth Month
- ClinicalTrials.gov ID
- NCT04499430
- Acronym / sponsor ID
- COTROPBSCF / KA-20053
- Conditions
- Premature Birth, Feeding Behavior
- Keywords
- complementary feeding, prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the transition time to the most appropriate complementary diet for premature babies
Time frame: 24 months
. 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.
1 secondary outcome
Reaching the targeted number of patients
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- complementary feedingLink provided by the sponsor.
- weaning and complementary feeding in premature babiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Feeding Behavior, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the transition time to the most appropriate complementary diet for premature babies (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.