This randomized clinical trial compared initiating oral feedings earlier at 30 weeks postmenstrual age (PMA) versus later at 33 weeks PMA in very premature infants born before 29 weeks gestation. The study aimed to determine if earlier initiation led to earlier attainment of full oral feedings and earlier hospital discharge. A total of 47 infants were randomly assigned to the earlier or later feeding groups. The results found no significant differences between the groups in attaining full oral feedings or hospital discharge. While starting oral feeds earlier appeared safe, it did not accelerate these outcomes. Larger studies may be needed to fully assess potential benefits of earlier feeding initiation.

1. Ann Gerges, MD, Polina Gelfer, MD, and Kathleen Kennedy, MD, MPH
The University of Texas Health Science Center Houston, TX
Randomized Trial of Earlier vs. Later Oral Feeding in Very Premature Infants
•The American Academy of Pediatrics Committee on the Fetus
and Newborn states that one of the physiologic competencies that
is essential prior to hospital discharge of a preterm infant is “oral
feeding sufficient to support appropriate growth.”
•For many of these infants, the inability to achieve oral feeding
competence is the last outstanding issue needing resolution prior
to discharge.
•Currently there is no consensus on the optimal postmenstrual
age (PMA) for introducing premature infants to oral feedings.
•To determine if earlier initiation of oral feedings at 30 weeks
PMA, compared with later initiation of oral feedings at 33 weeks
PMA, results in earlier attainment of full oral feedings and earlier
discharge from the hospital in premature infants born at <29
weeks gestation.
Design
•Randomized unmasked clinical trial
Sample Size
•33 patients per group necessary to detect 1.2 week difference
between groups (SD 1.6 weeks), using a power of 80% and alpha
value of 0.05
• Includes additional 10% for randomizing siblings of
multiple gestation to the same group
Enrollment
•Planned enrollment of 33 patients per group
Inclusion Criteria
•Inborn and outborn infants born <29 0
/7 weeks gestation
•Admitted to Children’s Memorial Hermann Hospital at <30 0
/7
weeks PMA between April 2013 to December 2014
•Tolerating enteral feedings for 3 continuous days at the time of
study randomization
Exclusion Criteria
•Craniofacial defects, neuromuscular disease, genetic disorders
•Cardiovascular disease
•Congenital gastrointestinal (GI) malformations or GI surgery
•Respiratory contraindications for oral feeding (e.g. CPAP)
Randomization
•Randomized/enrolled on the day the infant reached 30 0
/7 weeks
PMA to:
- Earlier oral feeding initiation at 30 0
/7 weeks PMA
- Later oral feeding initiation at 33 0
/7 weeks PMA
•Sealed, opaque, consecutively numbered envelopes with
variable block size
•Siblings from multiple gestation pregnancies were randomized to
the same group
Stratification by gestational age
•<26 0
/7
•≥26 0
/7 – 28 6
/7
BASELINE CHARACTERISTICS
PRIMARY OUTCOMES
Conclusions
Lor
STUDY FEEDING SCHEDULE
ENROLLMENT FLOW DIAGRAM
Introduction
Objective
Methods
Successful Feeding
•Oral completion of the full volume of a feeding ≤30 minutes
•No bradycardic episodes
•No clinical cyanosis or desaturation that requires a temporary increase in FiO2
≥0.20
Adverse Event
•Multiple bradycardic episodes (3 episodes of heart rate <100 beats per minute)
•Single severe bradycardia (heart rate <60 beats per minute)
•Bradycardia with choking episode
•Desaturations requiring a sustained increase in FiO2 ≥0.20 from baseline during a
feeding or for 6 hours after a feeding attempt
Results
Conclusions
Earlier Oral
Feeding
Group
(n=23)
Later Oral
Feeding
Group
(n=24)
Gestational age at birth in wks (mean + SD) 27.3 + 1.2 27.7 + 1.2
Birth weight in g (mean + SD) 1030 + 215 1073 + 261
Gender (n [%])
•Female
•Male
12 [52]
11 [48]
13 [54]
11 [46]
Race/Ethnicity (n [%])
•African American
•Hispanic
•Caucasian
•Asian
10 [44]
6 [26]
6 [26]
1 [4]
9 [37]
10 [42]
5 [21]
0 [0]
Weight at enrollment in g (mean + SD) 1138 + 183 1179 + 206
Volume of enteral feeding at enrollment in
mL/kg/d (mean + SD)
142 + 24 116 + 46
Respiratory support prior to enrollment in d
(median, [25th
, 75th
percentile])
•Mechanical ventilation
•NCPAP
•High flow nasal cannula
•Nasal cannula
2 [0, 2]
10 [5, 15]
0 [0, 0]
2 [0, 5]
1 [0, 2]
7.5 [5, 12.5]
0 [0, 0]
3 [0, 7]
Caffeine use prior to enrollment in d
(mean + SD)
19.2 + 7.5 16.5 + 8.2
0 oral
feedings/day
8 oral
feedings/day
1 oral
feeding/day
2 oral
feedings/day
3 oral
feedings/day
4 oral
feedings/day
6 oral
feedings/day
If <50% oral feeding
volume completed in 72
hours or adverse event
If successful without
adverse events for
1 day
P= <0.001
SECONDARY OUTCOMES
While starting oral feeding attempts in very premature infants at
30 weeks PMA appears to be safe, it does not lead to earlier
attainment of full oral feedings or hospital discharge. This study
may not have been powered sufficiently to exclude a clinically
significant difference.
Earlier Oral Feeding Group Later Oral Feeding Group
Earlier Oral Feeding Group Later Oral Feeding Group
Adverse Events
Earlier Oral
Feeding Group
Later Oral
Feeding Group
Multiple bradycardic episodes
(3 episodes of HR <100 bpm)
3 episodes in 1
patient
1 episode in 1 patient
Single severe bradycardia
(HR <60 bpm)
0 episodes 1 episode in 1 patient
Bradycardia with choking episode 6 episodes in 3
patients
2 episodes in 2
patients
Desaturation requiring sustained
increase in FiO2 ≥0.20 from baseline
during a feeding
1 episode in 1 patient 1 episode in 1 patient
Absolute increase in FiO2 ≥0.20 from
baseline for 6 hours after oral feeding
attempt
0 episodes 0 episodes
P= 0.69
P= 0.29
95% CI for difference between
groups
PMA at completion of all oral feedings in weeks -3.3 to +1.1
PMA at hospital discharge in weeks -2.5 to +1.7
Adverse Event