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

Premature Infants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05208437
• Other study ID #: [2021]394
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Infants

Intervention

Behavioral:
• Complete oral feeding intervention
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 group
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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During the procedure