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Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age

Study on the New Feeding Protocol of Promoting Very Preterm Infants to Attain Full Oral Feeding Earlier

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04277806
Enrollment
120
Registered
2020-02-20
Start date
2020-02-15
Completion date
2020-09-30
Last updated
2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

Brief summary

The investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.

Detailed description

In the neonatal intensive care unit, the attention of oral feeding of premature infants is far less than that of mechanical ventilation, antibiotics and other medical treatment, the use of parenteral nutrition, etc., and it is often not until the premature infants are enough mature and stable, or even before discharge that the caregivers pay attention to the problem of oral feeding. At this time, the corrected gestational age of premature infants is almost 36 weeks, but in fact the study shows that preterm infants have the ability of self feeding when they are about 32 weeks old. And oral feeding is very helpful to improve their nutritional status, reduce the use of parenteral nutrition and other forms of enteral nutrition, prevent complications and shorten the length of stay. Therefore, this study plans to use a new process to promote oral feeding and to verify whether it is feasible to earlier attainment of full oral feeding in premature infants.

Interventions

BEHAVIORALNew Oral feeding process

From the beginning of 32 weeks, try oral feeding once a day, suck pacifier for 10 minutes before feeding. When she/he can finish 50% of the amount of one meal in consecutive two days, and there is no adverse events happened, then we will try oral feeding twice a day. In the same way, in the oral feeding she/he can finish 50% of this meal in consecutive two days, there is no adverse events happened, then we will try three oral feedings three times a day. We wil continue the process until the infant can be fully oral fed by herself/himself.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The randomized allocation was concealed in double-enclosed, opaque, sealed and sequentially numbered envelops and opened when the infant was found to be eligible by the neonatal team in the NICU.

Intervention model description

Randomized controlled study. Standard group: old protocol. Intervention group: New protocol.

Eligibility

Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No

Inclusion criteria

* Preterm infants with gestational age less than 30 weeks * The parents are positive to treat the infants

Exclusion criteria

* Fetal edema * Very critical with OI more than 40 * Apgar score less than 5 at ten minutes after birth * The parents refuse to treat the infants * Severe IVH (more than grade IV ) * PVL * Died before oral feeding starts

Design outcomes

Primary

MeasureTime frameDescription
Age at full oral feedingDuring the procedureDays of life when the infant attain full oral feeding among two groups.

Secondary

MeasureTime frameDescription
The length of hospital stayDuring the procedureThe length of hospital stay of participates in two groups.
Incidence of complicationsDuring the procedureComplications include NecrotizingEnterocolitis,any infections,Intraventricular hemorrhage,Bronchopulmonary dysplasia,etc. The variables of complications will be set to 1 as any symptoms mentioned above appeared during the hospitalization and none for 0. The incidence would be calculated in two groups.
Corrected gestational age at full oral feedingDuring the procedureCorrected gestational age when the infant attain full oral feeding among two groups.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026