Premature InfantsNCT05208437
Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants
A study testing Complete oral feeding intervention and Routine nursing care group in people with Premature Infants, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants Read more about this study
- Who is it for?
- Ages 0 to 72 hours
- Conditions the study is for
- Premature Infants
- What is being tested?
- Complete oral feeding intervention and Routine nursing care group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Jul 2023
- Phase
- Interventional
- 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 0 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age <32w;
- Admit within 72 hours of birth;
- The guardian signs the informed consent;
- OI (oxygenation index >300)
Who cannot join
- Newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
- Newborns who die during the study;
- Newborns who drop out of the study;
- Newborns who have NEC during hospitalization
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants Whose Corrected Gestational Age Are Less Than 32 Weeks
Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants
Read the detailed description
In order to improve the feeding of premature infants <32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale.
Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. The whole intervention stops until the premature infant achieves the full oral feeding. Length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants <32 weeks of gestation.
- Conditions
- Premature Infants
- Being tested
- Complete oral feeding intervention, Routine nursing care group
- Keywords
- premature infants, oral feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete oral feeding interventionBehavioural
Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale by trained nurses. Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding. If the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant.
Routine nursing care groupBehavioural
Pre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding.
| Study group | Role | What they receive |
|---|---|---|
| Complete oral feeding intervention group | Experimental | Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale. Feeding of premature infants using different interventions based on the results of the Feeding Preparation Scale. Receives: Behavioral: Complete oral feeding intervention |
| Routine nursing care group | Active comparator | Pre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding. Routine nursing care is identical to the control group. Receives: Behavioral: Routine nursing care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition time from the initiation oral feeding to full oral feeding
Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle.
time of complete oral feeding
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Feb 2022
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojing Hu, PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208437
- Sponsor's protocol ID
- [2021]394
- Status last verified
- Feb 2023
- First submitted
- 30 Dec 2021
- Last updated
- 14 Aug 2023
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants Whose Corrected Gestational Age Are Less Than 32 Weeks
- ClinicalTrials.gov ID
- NCT05208437
- Acronym / sponsor ID
- [2021]394
- Conditions
- Premature Infants
- Keywords
- premature infants, oral feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 26 Jan 2022 (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.
Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants
Detailed description
In order to improve the feeding of premature infants <32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale.
Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. The whole intervention stops until the premature infant achieves the full oral feeding. Length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants <32 weeks of gestation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete oral feeding intervention group | Experimental | Behavioral: Complete oral feeding interventionPremature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale. Feeding of premature infants using different interventions based on the results of the Feeding Preparation Scale. |
| Routine nursing care group | Active comparator | Behavioral: Routine nursing care groupPre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding. Routine nursing care is identical to the control group. |
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age <32w;
- Admit within 72 hours of birth;
- The guardian signs the informed consent;
- OI (oxygenation index >300)
Key exclusion criteria (4 listed)
- Newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
- Newborns who die during the study;
- Newborns who drop out of the study;
- Newborns who have NEC during hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete oral feeding interventionPremature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale by trained nurses. Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding. If the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. | Behavioural | Complete oral feeding intervention group |
| Routine nursing care groupPre-feeding assessments will be performed from premature infants corrected for gestational age at 34 weeks. If the baby's vital signs are stable, the method of oral feeding and then nasal feeding is used, and feeding 8 to 12 times a day until the baby reaches complete oral feeding. | Behavioural | Routine nursing care group |
Primary outcome
Transition time from the initiation oral feeding to full oral feeding
Time frame: During the procedure
Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle. time of complete oral feeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
Xiaojing Hu, PhD principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete oral feeding intervention and Routine nursing care group in people with Premature Infants, run by Children's Hospital of Fudan University at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 14 Aug 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transition time from the initiation oral feeding to full oral feeding (time frame: During the procedure). 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 14 Aug 2023.