Trial Outcomes & Findings for Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth (NCT NCT05104073)

Last Updated: 2025-05-21

Results Overview

Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at birth, with length for age at birth and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Between birth and 6 months

Results posted on

2025-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. N=30 meeting inclusion/exclusion criteria	Control The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria
Overall Study STARTED	29	31
Overall Study COMPLETED	18	25
Overall Study NOT COMPLETED	11	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=29 Participants The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. N=30 meeting inclusion/exclusion criteria	Control n=31 Participants The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	29 Participants n=5 Participants	31 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Between birth and 6 months

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants For those with weight-for-length \<75th percentile, research staff provided parents with a recommendation for total daily formula volume to be consumed based upon energy requirement (kcal/kg/day) research conducted by Butte et al. that accounts for sex, weight, and current age. To provide guidance for what parents should expect over the next month, the child's weight-for-length percentile was reviewed. Parents were informed of the volume to expect at the subsequent visit in month with the expectation that the child would maintain the same weight-for-age percentile. For those with weight-for-length ≥75th percentile, recommended current daily formula volumes were calculated based upon the child's current age, weight, and energy requirement (kcal/kg/day) with a 10% reduction in recommended daily volume. Parents were also informed of the volume to expect at the subsequent visit in one month should the child maintain the same weight-for-age percentile, again with a 10% reduction.	Control n=31 Participants Usual care
Conditional Weight Gain Difference Between Study Groups	0.27 Conditional Weight Gain score Interval -0.2 to 0.75	-0.12 Conditional Weight Gain score Interval -0.62 to 0.37

SECONDARY outcome

Timeframe: During the intervention period spanning Ages 1-6 Months

Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at 1 month, with length for age at 1 month and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values.

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants For those with weight-for-length \<75th percentile, research staff provided parents with a recommendation for total daily formula volume to be consumed based upon energy requirement (kcal/kg/day) research conducted by Butte et al. that accounts for sex, weight, and current age. To provide guidance for what parents should expect over the next month, the child's weight-for-length percentile was reviewed. Parents were informed of the volume to expect at the subsequent visit in month with the expectation that the child would maintain the same weight-for-age percentile. For those with weight-for-length ≥75th percentile, recommended current daily formula volumes were calculated based upon the child's current age, weight, and energy requirement (kcal/kg/day) with a 10% reduction in recommended daily volume. Parents were also informed of the volume to expect at the subsequent visit in one month should the child maintain the same weight-for-age percentile, again with a 10% reduction.	Control n=30 Participants Usual care
Conditional Weight Gain Difference Between Study Groups	0.28 Conditional weight gain score Interval -0.2 to 0.77	-0.14 Conditional weight gain score Interval -0.63 to 0.35

SECONDARY outcome

Timeframe: 1 time point at age 6 Months

Weight-for-Length Z-score is based on values from the World Health Organization Growth Standards. A z-score of 0 represents the population mean. Positive values represent values above the population mean. Negative values represent values below the population mean

Outcome measures

Outcome measures
Measure	Intervention n=18 Participants For those with weight-for-length \<75th percentile, research staff provided parents with a recommendation for total daily formula volume to be consumed based upon energy requirement (kcal/kg/day) research conducted by Butte et al. that accounts for sex, weight, and current age. To provide guidance for what parents should expect over the next month, the child's weight-for-length percentile was reviewed. Parents were informed of the volume to expect at the subsequent visit in month with the expectation that the child would maintain the same weight-for-age percentile. For those with weight-for-length ≥75th percentile, recommended current daily formula volumes were calculated based upon the child's current age, weight, and energy requirement (kcal/kg/day) with a 10% reduction in recommended daily volume. Parents were also informed of the volume to expect at the subsequent visit in one month should the child maintain the same weight-for-age percentile, again with a 10% reduction.	Control n=25 Participants Usual care
Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards	0.73 Z-score Interval 0.16 to 1.3	0.65 Z-score Interval 0.28 to 1.03

SECONDARY outcome

Timeframe: Spanning ages 1-6 months

repeated measures analysis of weight-for-length

Outcome measures

Outcome measures
Measure	Intervention n=29 Participants For those with weight-for-length \<75th percentile, research staff provided parents with a recommendation for total daily formula volume to be consumed based upon energy requirement (kcal/kg/day) research conducted by Butte et al. that accounts for sex, weight, and current age. To provide guidance for what parents should expect over the next month, the child's weight-for-length percentile was reviewed. Parents were informed of the volume to expect at the subsequent visit in month with the expectation that the child would maintain the same weight-for-age percentile. For those with weight-for-length ≥75th percentile, recommended current daily formula volumes were calculated based upon the child's current age, weight, and energy requirement (kcal/kg/day) with a 10% reduction in recommended daily volume. Parents were also informed of the volume to expect at the subsequent visit in one month should the child maintain the same weight-for-age percentile, again with a 10% reduction.	Control n=30 Participants Usual care
Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period	12.4 kg/m Interval 12.1 to 12.7	12.1 kg/m Interval 11.8 to 12.3

SECONDARY outcome

Timeframe: 1 time point at age 6 months

% overweight by study group

Outcome measures

Outcome measures
Measure	Intervention n=18 Participants For those with weight-for-length \<75th percentile, research staff provided parents with a recommendation for total daily formula volume to be consumed based upon energy requirement (kcal/kg/day) research conducted by Butte et al. that accounts for sex, weight, and current age. To provide guidance for what parents should expect over the next month, the child's weight-for-length percentile was reviewed. Parents were informed of the volume to expect at the subsequent visit in month with the expectation that the child would maintain the same weight-for-age percentile. For those with weight-for-length ≥75th percentile, recommended current daily formula volumes were calculated based upon the child's current age, weight, and energy requirement (kcal/kg/day) with a 10% reduction in recommended daily volume. Parents were also informed of the volume to expect at the subsequent visit in one month should the child maintain the same weight-for-age percentile, again with a 10% reduction.	Control n=25 Participants Usual care
Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards)	4 Participants Interval 6.4 to 47.6	2 Participants Interval 1.0 to 26.0

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=29 participants at risk The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. N=30 meeting inclusion/exclusion criteria	Control n=31 participants at risk The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria
Metabolism and nutrition disorders Growth Faltering	41.4% 12/29 • 6 months Growth faltering defined as either: 1. Weight-for-length \<5th percentile for sex and age on the WHO growth chart 2. Downward crossing of \>2 major centile lines on the WHO growth chart (relevant major lines include 95th, 90th, 75th, 50th, 25th, 10th, 5th) after enrollment	41.9% 13/31 • 6 months Growth faltering defined as either: 1. Weight-for-length \<5th percentile for sex and age on the WHO growth chart 2. Downward crossing of \>2 major centile lines on the WHO growth chart (relevant major lines include 95th, 90th, 75th, 50th, 25th, 10th, 5th) after enrollment

Additional Information

Ian Paul, MD

Penn State College of Medicine

Phone: 7175318006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place