Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age
Primary Purpose
Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
New Oral feeding process
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm Infants
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard group
Intervention group
Arm Description
No interventions would be conducted in this group and the preterm infants would be fed in the normal way.
The preterm infants in this group would be fed according to the new process.
Outcomes
Primary Outcome Measures
Age at full oral feeding
Days of life when the infant attain full oral feeding among two groups.
Secondary Outcome Measures
The length of hospital stay
The length of hospital stay of participates in two groups.
Incidence of complications
Complications 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 feeding
Corrected gestational age when the infant attain full oral feeding among two groups.
Full Information
NCT ID
NCT04277806
First Posted
February 13, 2020
Last Updated
October 26, 2020
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT04277806
Brief Title
Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age
Official Title
Study on the New Feeding Protocol of Promoting Very Preterm Infants to Attain Full Oral Feeding Earlier
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study. Standard group: old protocol. Intervention group: New protocol.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard group
Arm Type
No Intervention
Arm Description
No interventions would be conducted in this group and the preterm infants would be fed in the normal way.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The preterm infants in this group would be fed according to the new process.
Intervention Type
Behavioral
Intervention Name(s)
New Oral feeding process
Intervention Description
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.
Primary Outcome Measure Information:
Title
Age at full oral feeding
Description
Days of life when the infant attain full oral feeding among two groups.
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
The length of hospital stay
Description
The length of hospital stay of participates in two groups.
Time Frame
During the procedure
Title
Incidence of complications
Description
Complications 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.
Time Frame
During the procedure
Title
Corrected gestational age at full oral feeding
Description
Corrected gestational age when the infant attain full oral feeding among two groups.
Time Frame
During the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
12. IPD Sharing Statement
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Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age
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