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

NCT ID: NCT04277806

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled study. Standard group: old protocol. Intervention group: New protocol.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Standard group

No interventions would be conducted in this group and the preterm infants would be fed in the normal way.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

The preterm infants in this group would be fed according to the new process.

Group Type EXPERIMENTAL

New Oral feeding process

Intervention Type BEHAVIORAL

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.

Interventions

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New 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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2019-298

Identifier Type: -

Identifier Source: org_study_id