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Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants

Primary Purpose

Premature Infants

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Complete oral feeding intervention
Routine nursing care group
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Infants focused on measuring premature infants, oral feeding

Eligibility Criteria

0 Hours - 72 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age <32w;
  • Admit within 72 hours of birth;
  • The guardian signs the informed consent;
  • OI (oxygenation index >300)

Exclusion Criteria:

  • 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

Sites / Locations

  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Complete oral feeding intervention group

Routine nursing care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 30, 2021
Last Updated
August 9, 2023
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05208437
Brief Title
Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
July 31, 2023 (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
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants
Keywords
premature infants, oral feeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complete oral feeding intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine nursing care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Complete oral feeding intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine nursing care group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transition time from the initiation oral feeding to full oral feeding
Description
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
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age <32w; Admit within 72 hours of birth; The guardian signs the informed consent; OI (oxygenation index >300) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojing Hu, PhD
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
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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Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants

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